Identity
- Device Name
- Optical Biometers EUDAMED
- Model / Reference
- AL550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945087555019 EUDAMED
- Basic UDI-DI
- 69450875OpticalBiometerFE EUDAMED
- Direct Marketing DI
- 06945087555019 EUDAMED
- EMDN Code
- Z12120102 COMPUTERISED OPTICAL BIOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optical Biometers by Shanghai Mediworks Precision Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69450875OpticalBiometerFE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai Mediworks Precision Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000004251
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED daae7c42-a3ab-4007-8adc-ba70994eca4d 61 fields · synced Jul 25, 2026