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Ty-E8
EUDAMEDClass I (EU MDR)
Ref z1211Model TY-E8,TY-E9,TY-5,TY-10,TY-11,TY-20,TY-30,TY-40
Identity
- Trade Name
- TY-E8 EUDAMED
- Device Name
- Dental Camera EUDAMED
- Model / Reference
- TY-E8,TY-E9,TY-5,TY-10,TY-11,TY-20,TY-30,TY-40 EUDAMEDz1211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975909340080 EUDAMED
- Basic UDI-DI
- 697590934cameraTF EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental delivery system
Ty-E8 by Foshan Toye Dental Equipment Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697590934cameraTF | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Foshan Toye Dental Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000022808
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 42bee5e6-cef2-450a-b489-d5d8870cfd54 61 fields · synced Jul 21, 2026