← Back to catalogue
AII Calibrators
EUDAMEDClass B (EU MDR)
Ref 105-051448-00Model 105-049533-00、105-049532-00、105-051448-00、
Identity
- Trade Name
- AII Calibrators EUDAMED
- Device Name
- Angiotensin Ⅱ(CLIA)、AII Calibrators EUDAMED
- Model / Reference
- 105-049533-00、105-049532-00、105-051448-00、 EUDAMED105-051448-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06903053098168 EUDAMED
- Basic UDI-DI
- 69449040AB74000715T EUDAMED
- EMDN Code
- W0102060202 ANGIOTENSIN I / II EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
AII Calibrators by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69449040AB74000715T | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 543319c5-3f02-4b76-ae32-66349646664c 61 fields · synced Jun 19, 2026