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EUDAMED Device Search

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

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124 device results listed.

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D-TPS-U402U6

TPS-U402

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-TPS-U402U6
Basic UDI-DI: B-TPS-U402U6
Reference: TPS-U402
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-ITB-402SL

ITB-402

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-ITB-402SL
Basic UDI-DI: B-ITB-402SL
Reference: ITB-402
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-ISY-U401RL

ISY-U401

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-ISY-U401RL
Basic UDI-DI: B-ISY-U401RL
Reference: ISY-U401
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-IST-502YJ

IST-502

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-IST-502YJ
Basic UDI-DI: B-IST-502YJ
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-IST-501YG

IST-501

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-IST-501YG
Basic UDI-DI: B-IST-501YG
Reference: IST-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-IIN-501SC

IIN-501

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-IIN-501SC
Basic UDI-DI: B-IIN-501SC
Reference: IIN-501
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-IHP-402SJ

IHP-402

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-IHP-402SJ
Basic UDI-DI: B-IHP-402SJ
Reference: IHP-402
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-ICH-502MW

ICH-502

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-ICH-502MW
Basic UDI-DI: B-ICH-502MW
Reference: ICH-502
EMDN: W0105090101
EMDN description: CHLAMYDIA AG - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-FHC-U1028M

hCG One Step Ultra Pregnancy Test Device (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-FHC-U1028M
Basic UDI-DI: B-FHC-U1028M
Reference: FHC-U102
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-FHC-201L4

FHC-201

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-FHC-201L4
Basic UDI-DI: B-FHC-201L4
Reference: FHC-201
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-FHC-102KZ

FHC-102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-FHC-102KZ
Basic UDI-DI: B-FHC-102KZ
Reference: FHC-102
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-FHC-101KX

FHC-101

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-FHC-101KX
Basic UDI-DI: B-FHC-101KX
Reference: FHC-101
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

16952999401331

UPK009C

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 16952999401331
Basic UDI-DI: B-16952999401331
Reference: UPK009C
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 11.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

16952999401324

IST-502

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 16952999401324
Basic UDI-DI: B-16952999401324
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 11.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

16952999401317

IST-501

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 16952999401317
Basic UDI-DI: B-16952999401317
Reference: IST-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 11.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

ABON™

IHBsg-402001

IVD Class DIVDR 2017/746Not intended for EU marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999410008
Basic UDI-DI: 69529994HBV0001X4
Reference: IHBsg-402001
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: -
Safety summary (SSCP/SSP): IVDRTF-0010 CH7.4 · Rev. 4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

06952999408944

TFO-602

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999408944
Basic UDI-DI: B-06952999408944
Reference: TFO-602
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

06952999408937

TFO-602

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999408937
Basic UDI-DI: B-06952999408937
Reference: TFO-602
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

06952999408845

IHP-602

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999408845
Basic UDI-DI: B-06952999408845
Reference: IHP-602
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

06952999408838

IHP-602

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999408838
Basic UDI-DI: B-06952999408838
Reference: IHP-602
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details