Identity
- Trade Name
- Teeth Opener EUDAMED
- Device Name
- Teeth Opener EUDAMED
- Model / Reference
- 1607-9001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182603052 EUDAMED
- Basic UDI-DI
- B-04711182603052 EUDAMED
- EMDN Code
- R030280 RESPIRATORY BALLONS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Teeth Opener by Fortune Medical Instrument Corp. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04711182603052 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 3ccf2a20-2351-4077-8b1b-9ad8f22641a4 61 fields · synced Jun 18, 2026