Identity
- Trade Name
- ZEISS EUDAMEDMYO 200 EUDAMED
- Device Name
- Optical Biometer EUDAMED
- Model / Reference
- MYO 200 EUDAMED9209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977585090198 EUDAMED
- Basic UDI-DI
- 697758509_004_RG EUDAMED
- Direct Marketing DI
- 06977585090198 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
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Zeiss by Carl Zeiss Meditec (Suzhou) 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 | 697758509_004_RG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000044920
- Authorised Representative
- Carl Zeiss Meditec AG DE-AR-000007733
Sources (2)
- EUDAMED dedfdb24-fdb7-4696-8a86-460702d7cd3e 61 fields · synced Jun 19, 2026
- EUDAMED eef39e41-e914-4ea6-bb42-7dfe6e5297f6 61 fields · synced Jun 19, 2026