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Forming Sheet
EUDAMEDClass I (EU MDR)
Ref 9515.00 Model 9515.00,9516.01,9516.02 Ref 9507.01 Model 9507.01,9507.02,9508.00
Identity
- Device Name
- Forming Sheet EUDAMEDForming Sheet Clip EUDAMED
- Model / Reference
- 9515.00,9516.01,9516.02 EUDAMED9515.00 EUDAMED9507.01,9507.02,9508.00 EUDAMED9507.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978315816637 EUDAMED06978315816569 EUDAMED
- Basic UDI-DI
- 697831581FormingsheetC9 EUDAMED697831581Sheetclip84 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
Forming Sheet 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 | 697831581FormingsheetC9 | 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 (2)
- EUDAMED f6cee470-7123-4c86-a579-4c89753ed200 61 fields · synced Jul 12, 2026
- EUDAMED 3e968af8-e00c-4f17-81c9-c1c76bd7a9ab 61 fields · synced May 18, 2026