← Back to catalogue
Dental Sheet
EUDAMEDClass I (EU MDR)
Ref T040Model T040,T050,T063,T076,T088,T100,T150,T200 P040,P050,P063,P076,P088,P100,P150,P200 C040,C050,C063,C076,C088,C100,C150,C200 MUL076,MUL100,MUL150,MUL175,MUL200,MUL250,MUL300,MUL350,MUL400,MUL450,MUL500,MUL550,MUL600
Identity
- Device Name
- Dental Sheet EUDAMED
- Model / Reference
- T040,T050,T063,T076,T088,T100,T150,T200 P040,P050,P063,P076,P088,P100,P150,P200 C040,C050,C063,C076,C088,C100,C150,C200 MUL076,MUL100,MUL150,MUL175,MUL200,MUL250,MUL300,MUL350,MUL400,MUL450,MUL500,MUL550,MUL600 EUDAMEDT040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975683900005 EUDAMED
- Basic UDI-DI
- 697568390012S EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - 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
Dental Sheet by Changzhou Ou Nuo Medical Equipment 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 | 697568390012S | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Changzhou Ou Nuo Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000028248
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 00a6ac86-bf25-4372-a913-93d483aed352 61 fields · synced Oct 6, 2026