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Wedge
EUDAMEDClass I (EU MDR)
Ref 06978315815951Model 9101.01, 9101.02, 9101.03, 9101.04, 9102.01, 9102.02, 9102.03, 9102.04, 9103.00, 9104.01, 9104.02, 9104.03, 9104.04, 9105.01, 9105.02, 9105.03, 9502.00, 9503.00, 9504.01, 9504.02, 9504.03, 9509.00
Identity
- Device Name
- Wedge EUDAMED
- Model / Reference
- 9101.01, 9101.02, 9101.03, 9101.04, 9102.01, 9102.02, 9102.03, 9102.04, 9103.00, 9104.01, 9104.02, 9104.03, 9104.04, 9105.01, 9105.02, 9105.03, 9502.00, 9503.00, 9504.01, 9504.02, 9504.03, 9509.00 EUDAMED06978315815951 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978315815951 EUDAMED
- Basic UDI-DI
- 697831581Wedge9B 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
Wedge 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 | 697831581Wedge9B | 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 2a1f427a-f949-483d-a89f-597e878e49f3 61 fields · synced Jun 20, 2026