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Sleeve
EUDAMEDClass I (EU MDR)
Ref 9523.01 Model 9523.01, 9523.02, 9523.03A, 9523.03B, 9523.04, 9523.05, 9523.06
Identity
- Device Name
- Sleeve EUDAMED
- Model / Reference
- 9523.01, 9523.02, 9523.03A, 9523.03B, 9523.04, 9523.05, 9523.06 EUDAMED9523.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978315815494 EUDAMED
- Basic UDI-DI
- 697831581SleeveNP EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - 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
Sleeve 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 | 697831581SleeveNP | 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 d40ff664-17ee-4f74-9040-7a54a5494755 61 fields · synced Jun 18, 2026