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DAVID, Family Care Med+, Z1 Pharma , KTX7
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref HCG-HS, HCG-MS, HCG-MS1, HCG-LSModel HCG-HS (HCG 10mIU/mL), HCG-MS (HCG15mIU/mL), HCG-MS1 (HCG20mIU/mL), HCG-LS (HCG25mIU/mL)
Identity
- Trade Name
- DAVID, Family Care Med+, Z1 Pharma , KTX7 EUDAMED
- Device Name
- One Step Pregnancy Urine Test for Self-testing EUDAMED
- Model / Reference
- HCG-HS (HCG 10mIU/mL), HCG-MS (HCG15mIU/mL), HCG-MS1 (HCG20mIU/mL), HCG-LS (HCG25mIU/mL) EUDAMEDHCG-HS, HCG-MS, HCG-MS1, HCG-LS EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-RH-HCGE4 EUDAMED
- Basic UDI-DI
- B-RH-HCGE4 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
DAVID, Family Care Med+, Z1 Pharma , KTX7 by Equinox Biotech Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-RH-HCGE4 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Equinox Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000018901
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 8f58f9f0-f5a6-4fe6-a8c1-7f8e966e590f 61 fields · synced Jun 19, 2026
- EUDAMED 8f58f9f0-f5a6-4fe6-a8c1-7f8e966e590f-1 61 fields · synced Jun 9, 2026