Identity
- Trade Name
- Aligner Chewies EUDAMED
- Device Name
- Orthodontic material device EUDAMED
- Model / Reference
- MP03,MP04,DB21 EUDAMEDMP03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454004852 EUDAMED06954454002162 EUDAMED06954454002179 EUDAMED06954454000878 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
Aligner Chewies 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 (4)
- EUDAMED 50373b41-5137-4342-9341-4012f8df814a 61 fields · synced Oct 5, 2026
- EUDAMED a37187b8-5e63-49cb-ba14-0533d737bd3f 61 fields · synced May 16, 2026
- EUDAMED ace33dc8-56f0-419c-8ce4-85d2cb771316 61 fields · synced May 18, 2026
- EUDAMED c5f76bb1-46cc-4699-9e6c-b92ebf3f8c09 61 fields · synced May 19, 2026