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Invisible Braces Box
EUDAMEDClass I (EU MDR)
Ref DB21Model MP03,MP04,DB21Ref DB22A
Identity
- Trade Name
- Invisible Braces Box EUDAMED
- Device Name
- Orthodontic material device EUDAMED
- Model / Reference
- MP03,MP04,DB21 EUDAMEDDB21 EUDAMEDDB22A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454004807 EUDAMED06954454012802 EUDAMED
- Basic UDI-DI
- 69544540ORMD001W9 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC 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
Invisible Braces Box by Huanghua Promisee Dental 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 | 69544540ORMD001W9 | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED f4cd9df9-7a39-4b60-9dd0-c1453375c719 61 fields · synced Oct 6, 2026
- EUDAMED 5e39f0f8-3c3d-42f4-bf54-622d8e0c2091 61 fields · synced May 19, 2026