← Back to catalogue
HbA1C Rapid Test Strip (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref H010916D
Identity
- Trade Name
- HbA1C Rapid Test Strip (Colloidal Gold) EUDAMED
- Model / Reference
- H010916D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792053878 EUDAMED
- Basic UDI-DI
- B-06971792053878 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HbA1C Rapid Test Strip (Colloidal Gold) by Hangzhou Realy Tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06971792053878 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED b52eac1a-25c8-4fef-975f-02a6e24a9f21 61 fields · synced Jul 25, 2026