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D-697994388Ir0393PEK

FOB/TF Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0393PEK
Basic UDI-DI: B-697994388Ir0393PEK
Reference: Ir039
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0383ME8

TF Transferrin Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0383ME8
Basic UDI-DI: B-697994388Ir0383ME8
Reference: Ir038
EMDN: W0101060301
EMDN description: GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0373KDX

FOB Fecal Occult Blood Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0373KDX
Basic UDI-DI: B-697994388Ir0373KDX
Reference: Ir037
EMDN: W0101060302
EMDN description: ALBUMIN IN STOOL (MECONIUM)
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-69750225321171CEKWTC

Total Cholesterol Test Strips

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: D-69750225321171CEKWTC
Basic UDI-DI: B-69750225321171CEKWTC
Reference: EN600TC1、EN600TC2、EN600TC3
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-69750225320175CEL5S6

iCR 10,iCR 11

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: D-69750225320175CEL5S6
Basic UDI-DI: B-69750225320175CEL5S6
Reference: iCR 10,iCR 11
EMDN: W0101060112
EMDN description: CREATININE ANALYSIS TEST STRIPS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-69750225320174CEKYTW

Blood Uric Acid Test Strips

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: D-69750225320174CEKYTW
Basic UDI-DI: B-69750225320174CEKYTW
Reference: EN400R1、EN400R2、 EN400R3、EN400R4、
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-69750225320171CEKHRT

Blood Lactate Test Strips

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: D-69750225320171CEKHRT
Basic UDI-DI: B-69750225320171CEKHRT
Reference: EN300R1、EN300R2、EN300R3、EN300R4
EMDN: W0101060104
EMDN description: LACTATE TEST STRIPS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-69750225320121CEJEPH

Blood Gas Test Cartridges

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: D-69750225320121CEJEPH
Basic UDI-DI: B-69750225320121CEJEPH
Reference: see the instructions for use
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-69750225319171CENMX2

Blood Glucose Test Strips

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: D-69750225319171CENMX2
Basic UDI-DI: B-69750225319171CENMX2
Reference: EN200R1、EN200R2、EN200R3、EN200R4
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-69750225319172CENSXR

Blood β-Ketone Test Strips

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: D-69750225319172CENSXR
Basic UDI-DI: B-69750225319172CENSXR
Reference: EN500R1、EN500R2、 EN500R3、 EN500R4
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analysis Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646URS001T9CW
Basic UDI-DI: B-697424646URS001T9CW
Reference: URS-1**1
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analysis Test Strip(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646URS000T7CM
Basic UDI-DI: B-697424646URS000T7CM
Reference: URS-1111
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

BV pH Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646PH001GSKD
Basic UDI-DI: B-697424646PH001GSKD
Reference: PH-6011/PH-6012
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

BV pH Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646PH000GQK4
Basic UDI-DI: B-697424646PH000GQK4
Reference: PH-6011/PH-6012
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Urine strip test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309294
Basic UDI-DI: B-69743840309294
Reference: 3034502
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginitis Multi-Test(Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MVA001MF33
Basic UDI-DI: B-697424646MVA001MF33
Reference: MVA-6**1C/MVA-6**2C
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginitis Multi-test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MVA000MD2S
Basic UDI-DI: B-697424646MVA000MD2S
Reference: MVA-6**1C/MVA-6**2C
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood FIA Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FOB000FKQ5Q
Basic UDI-DI: B-697424646FOB000FKQ5Q
Reference: FOB-5012F
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Faecal Occult Blood Rapid Test Kit(Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FOB000GCSL
Basic UDI-DI: B-697424646FOB000GCSL
Reference: FOB-5011/FOB-5012
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test(Milk)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC003DPPF
Basic UDI-DI: B-697424646ALC003DPPF
Reference: ALC-8011/ALC-8012/ALC-8014
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details