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Safe AQ max Ⅲ
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 6D001DDModel Safe AQ max ⅢRef 6D005DDModel Safe AQ max IIIRef 6D004DD
Identity
- Trade Name
- Safe AQ max Ⅲ EUDAMED
- Device Name
- Blood Glucose Meter EUDAMEDBlood Glucose Test Strip EUDAMED
- Model / Reference
- Safe AQ max Ⅲ EUDAMED6D001DD EUDAMEDSafe AQ max III EUDAMED6D005DD EUDAMED6D004DD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175004584 EUDAMED06934175008445 EUDAMED06934175004652 EUDAMED
- Basic UDI-DI
- B-06934175004584 EUDAMEDB-06934175008445 EUDAMEDB-06934175004652 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
- Ireland 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
Safe AQ max Ⅲ 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-06934175004584 | Class IVD Annex II List B | 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 (3)
- EUDAMED ab72ece6-3db6-4820-b13a-a867d9fd135f 61 fields · synced Aug 4, 2026
- EUDAMED 1ade96c4-1e30-4a99-bf3b-43383b4ea58b 61 fields · synced May 17, 2026
- EUDAMED 4e791fe4-c01f-4340-af0b-6c71deeb041d 61 fields · synced May 18, 2026