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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

17.07.2026 05:10

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Chagas Rapid Test (Whole Blood/Serum/Plasma)

Chagas Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CHA000CHLM
Basic UDI-DI: B-697424646CHA000CHLM
Reference: CHA-4011/CHA-4012
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotein Rapid Test (Feces)

Calprotein Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CAL000CHMD
Basic UDI-DI: B-697424646CAL000CHMD
Reference: CAL-5012
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Benzodiazepine(BZO) Rapid Test Kit(Urine)

Benzodiazepine(BZO) Rapid Test Kit(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646BZO000MC3Z
Basic UDI-DI: B-697424646BZO000MC3Z
Reference: BZO-1011/BZO-1012/BZO-1014
EMDN: W0102160504
EMDN description: BENZODIAZEPINES - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine(BUP) Rapid Test Kit(Urine)

Buprenorphine(BUP) Rapid Test Kit(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646BUP000KU2P
Basic UDI-DI: B-697424646BUP000KU2P
Reference: BUP-1011/BUP-1012/BUP-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Brucella IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)

Brucella IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646BRU000KW39
Basic UDI-DI: B-697424646BRU000KW39
Reference: BRU-4022
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Barbiturates(BAR) Rapid Test Kit(Urine)

Barbiturates(BAR) Rapid Test Kit(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646BAR000DEP5
Basic UDI-DI: B-697424646BAR000DEP5
Reference: BAR-1011/BAR-1012/BAR-1014
EMDN: W0102160503
EMDN description: BARBITURATES - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Amphetamine(AMP) Rapid Test Kit(Urine)

Amphetamine(AMP) Rapid Test Kit(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646AMP000GPV3
Basic UDI-DI: B-697424646AMP000GPV3
Reference: AMP-1011/AMP-1012/AMP-1014
EMDN: W0102160501
EMDN description: AMPHETAMINES - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test Kit(Urine)

Alcohol Rapid Test Kit(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC000DHNG
Basic UDI-DI: B-697424646ALC000DHNG
Reference: ALC-1011/ALC-1012/ALC-1014
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test Kit(Saliva)

Alcohol Rapid Test Kit(Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC(S)000DHTJ
Basic UDI-DI: B-697424646ALC(S)000DHTJ
Reference: ALC-7011/ALC-7014
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Micro-Albumin Rapid Test Kit(Urine)

Micro-Albumin Rapid Test Kit(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALB000DAMM
Basic UDI-DI: B-697424646ALB000DAMM
Reference: ALB-1011/ALB-1012/ALB-1014
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test Kit(Milk)

Alcohol Rapid Test Kit(Milk)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC(M)000DHQC
Basic UDI-DI: B-697424646ALC(M)000DHQC
Reference: ALC-8011/ALC-8014
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Rapid Test (Feces)

Adenovirus Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ADV000EWSY
Basic UDI-DI: B-697424646ADV000EWSY
Reference: ADV-5011/ADV-5012
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Adulteration Test (Urine)

Urine Adulteration Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ADU000EPS5
Basic UDI-DI: B-697424646ADU000EPS5
Reference: ADU-1061
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Total Nucleic Acid Extraction Kit (500ul)

TRUPCR® Total Viral Nucleic Acid Extraction Kit (500ul)

IVD generalIVDDOn the marketKitReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: D-5061021472257PJ
Basic UDI-DI: B-5061021472257PJ
Reference: 3B213
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BS DNA Extraction Kit

TRUPCR® BS DNA Extraction Kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: D-5061021472240NZ
Basic UDI-DI: B-5061021472240NZ
Reference: 3B215
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

U87E

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Urion Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018740
UDI-DI: 06953825911522
Basic UDI-DI: B-06953825911522
Reference: 06953825911522
EMDN: Z1203020501
EMDN description: NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES
First on market country: Poland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

UFR201

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Urion Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018740
UDI-DI: 06953825911461
Basic UDI-DI: B-06953825911461
Reference: 06953825911461
EMDN: V0301010299
EMDN description: DIGITAL THERMOMETERS - OTHER
First on market country: Poland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

U61H

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Urion Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018740
UDI-DI: 06953825911454
Basic UDI-DI: B-06953825911454
Reference: 06953825911454
EMDN: Z1203020501
EMDN description: NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

U80Z

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Urion Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018740
UDI-DI: 06953825910907
Basic UDI-DI: B-06953825910907
Reference: 06953825910907
EMDN: Z1203020501
EMDN description: NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

vitalio Early Pregnancy test

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: 06942468139202
Basic UDI-DI: B-06942468139202
Reference: ACK21001- M02-001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details