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Model base set
EUDAMEDClass I (EU MDR)
Ref 9521.01 Model 9521.01,9521.02,9521.03
Identity
- Device Name
- Model base set EUDAMED
- Model / Reference
- 9521.01,9521.02,9521.03 EUDAMED9521.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978315816712 EUDAMED
- Basic UDI-DI
- 697831581ModelbasesetUB 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
Model base set 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 | 697831581ModelbasesetUB | 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 fcfc6d9d-aeb4-4e67-b527-6f3fb9a3f70f 61 fields · synced Jul 11, 2026