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Blood Glucose Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 5Y002, 5Z002, 6A002, 6B002, 6B003, 6C001, 6C002, 6C003, 6C004, 6C005, 6C006, 6C007, 6D004, 6D005, 6D006Model Safe AQ pro Ⅰ, Safe AQ pro Ⅱ, Safe AQ pro Ⅲ; Safe AQ maxⅠ, Safe AQ maxⅡ, Safe AQ max Ⅲ
Identity
- Device Name
- Blood Glucose Test Strip EUDAMED
- Model / Reference
- Safe AQ pro Ⅰ, Safe AQ pro Ⅱ, Safe AQ pro Ⅲ; Safe AQ maxⅠ, Safe AQ maxⅡ, Safe AQ max Ⅲ EUDAMED5Y002, 5Z002, 6A002, 6B002, 6B003, 6C001, 6C002, 6C003, 6C004, 6C005, 6C006, 6C007, 6D004, 6D005, 6D006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-01B0111Y6 EUDAMED
- Basic UDI-DI
- B-01B0111Y6 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS 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
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Blood Glucose Test Strip by Changsha Sinocare Inc. — Class IVD devices for self-testing — 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-01B0111Y6 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED ed0b6f31-1823-4973-8683-2dc5235daf13 61 fields · synced Jun 19, 2026
- EUDAMED ed0b6f31-1823-4973-8683-2dc5235daf13-1 61 fields · synced Jun 10, 2026