Identity
- Trade Name
- Diamond Wedges EUDAMEDDiamond Wedges W4 3.0 EUDAMED
- Device Name
- Wedges EUDAMED
- Model / Reference
- DIW0800B EUDAMEDDIW1001 EUDAMEDDIW1005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971241391810 EUDAMED06971241393418 EUDAMED06971241393456 EUDAMED
- Basic UDI-DI
- 697124139DIW0001EV EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Diamond Wedges by Tangshan Zhengtong Exhibition 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 | 697124139DIW0001EV | Class I | Active |
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Manufacturer
- Manufacturer
- Tangshan Zhengtong Exhibition Co., Ltd.
- EUDAMED SRN
- CN-MF-000018452
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (3)
- EUDAMED 5a8b1f54-ac60-43b7-a9fc-012313fdf293 61 fields · synced Oct 6, 2026
- EUDAMED 86764a6c-549d-4158-8025-1650b1bf9d18 61 fields · synced May 17, 2026
- EUDAMED 9538ef7b-e403-4011-8344-05035b57b1e4 61 fields · synced May 19, 2026