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Dental external abrasive material
EUDAMEDClass I (EU MDR)
Ref OW-12-1Model OW-12-1 OW-12-2 OW-12-3
Identity
- Device Name
- Dental external abrasive material EUDAMED
- Model / Reference
- OW-12-1 OW-12-2 OW-12-3 EUDAMEDOW-12-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975702481089 EUDAMED
- Basic UDI-DI
- 697570248DEAM01GV EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS 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
Dental external abrasive material by Dongguan Ouwen Medical Device 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 | 697570248DEAM01GV | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Ouwen Medical Device Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000013171
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 1a27aa41-40b4-4941-a734-33a7454e445a 61 fields · synced Jun 18, 2026