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Tray
EUDAMEDClass I (EU MDR)
Ref 9201.01 Model 9114.01, 9114.02, 9114.03, 9115.01, 9115.02, 9115.03, 9116.01, 9116.02
Identity
- Device Name
- Tray EUDAMED
- Model / Reference
- 9114.01, 9114.02, 9114.03, 9115.01, 9115.02, 9115.03, 9116.01, 9116.02 EUDAMED9201.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978315816361 EUDAMED
- Basic UDI-DI
- 697831581RolldividerLA EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Tray by Wuxi Weller Technology 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 | 697831581RolldividerLA | Class I | Active |
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Manufacturer
- Manufacturer
- Wuxi Weller Technology Co., LTD
- EUDAMED SRN
- CN-MF-000046706
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 40f44357-9bbc-4275-ba54-9728499fbe55 61 fields · synced Jul 27, 2026