Identity
- Trade Name
- Orthodontic Elastics EUDAMED
- Device Name
- Orthodontic Elastics EUDAMED
- Model / Reference
- ORT-E634-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941985548276 EUDAMED
- Basic UDI-DI
- 69419855DTCTL100016Q EUDAMED
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
Classification
- Device Class
- Class IIa 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
Orthodontic Elastics by Hangzhou DTC Medical Apparatus Co., Ltd — Class IIa — 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 | 69419855DTCTL100016Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou DTC Medical Apparatus Co., Ltd
- EUDAMED SRN
- CN-MF-000032021
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f5462da8-c0dd-407f-9630-483aec7346ca 61 fields · synced Oct 7, 2026