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ACEZIN AMIGold mini Blood Glucose Monitoring System
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref AM10 CD
Identity
- Trade Name
- ACEZIN AMIGold mini Blood Glucose Monitoring System EUDAMED
- Device Name
- ACEZIN AMIGold mini Blood Glucose Monitoring System EUDAMED
- Model / Reference
- AM10 CD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719880650248 EUDAMED
- Basic UDI-DI
- B-04719880650248 EUDAMED
- EMDN Code
- W0101060101,W010106010801,W0201060102 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
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
ACEZIN AMIGold mini Blood Glucose Monitoring System by Ace Medical Technology Co., Ltd. — Class IVD Annex II List B — 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-04719880650248 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Ace Medical Technology Co., Ltd.
- EUDAMED SRN
- TW-MF-000031329
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 02997a77-b9be-4858-bec8-690d81bdae42 61 fields · synced Jun 19, 2026