Identity
- Trade Name
- Mouth Opener EUDAMED
- Device Name
- Mouth Opener EUDAMED
- Model / Reference
- TW8401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970385724010 EUDAMED
- Basic UDI-DI
- 6970385728401MOZV EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Mouth Opener by Xiamen Tianzuo Medical 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 | 6970385728401MOZV | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Tianzuo Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000018733
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED eb148834-0b54-4a52-b3ac-2ceae6073eaf 61 fields · synced Jul 9, 2026