← Back to catalogue
Safe-Accu2
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 5D001DDModel Safe-Accu2Ref 5D002DDModel Safe-Accu2
Identity
- Trade Name
- Safe-Accu2 EUDAMED
- Device Name
- Blood Glucose Meter EUDAMEDBlood Glucose Test Strip EUDAMED
- Model / Reference
- Safe-Accu2 EUDAMED5D001DD EUDAMED5D002DD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175037421 EUDAMED06934175037438 EUDAMED
- Basic UDI-DI
- B-06934175037421 EUDAMEDB-06934175037438 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMEDW0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
Safe-Accu2 by Changsha Sinocare Inc. — Class IVD Annex II List B — 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-06934175037421 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 0a7b89c8-31bd-4054-a073-726c8baf4f4f 61 fields · synced Jul 18, 2026
- EUDAMED be27d162-8fda-48dd-85cb-914d913b9ff7 61 fields · synced May 18, 2026