Identity
- Trade Name
- READY TO WEAR SPECTACLES EUDAMED
- Device Name
- Ready-to-wear spectacles EUDAMED
- Model / Reference
- A100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978857320012 EUDAMED
- Basic UDI-DI
- 6978857320904K8 EUDAMED
- EMDN Code
- Q0210030102 READY TO WEAR PLASTIC SPECTACLES WITH ORGANIC LENSES EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ready To Wear Spectacles by Taizhou Zongrong Yanjing Co., Ltd. — Class I — 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 | 6978857320904K8 | Class I | Active |
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Manufacturer
- Manufacturer
- Taizhou Zongrong Yanjing Co., Ltd.
- EUDAMED SRN
- CN-MF-000048411
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 9c1141d4-7428-4942-af8d-6eb8cbcebea4 61 fields · synced Oct 6, 2026