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Orthodontic Elastics
EUDAMEDClass IIa (EU MDR)
Ref A644-64Ref A641-48Ref A642-32Ref A644-32Ref A641-64-SiRef A642-48-SiRef A643-48-SiRef A643-32Ref A643-32-SiRef A643-79Ref E632-02FRef A641-79Ref E631-01Ref A644-95Ref A642-79Ref A641-32Ref E631-02Ref A643-64Ref A644-32-SiRef A644-64-SiRef E632-01
Identity
- Trade Name
- Orthodontic Elastics EUDAMED
- Device Name
- Orthodontic Elastics EUDAMED
- Model / Reference
- A644-64 EUDAMEDA641-48 EUDAMEDA642-32 EUDAMEDA644-32 EUDAMEDA641-64-Si EUDAMEDA642-48-Si EUDAMEDA643-48-Si EUDAMEDA643-32 EUDAMEDA643-32-Si EUDAMEDA643-79 EUDAMEDE632-02F EUDAMEDA641-79 EUDAMEDE631-01 EUDAMEDA644-95 EUDAMEDA642-79 EUDAMEDA641-32 EUDAMEDE631-02 EUDAMEDA643-64 EUDAMEDA644-32-Si EUDAMEDA644-64-Si EUDAMEDE632-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941985512659 EUDAMED06941985512390 EUDAMED06941985512444 EUDAMED06941985512611 EUDAMED06941985512413 EUDAMED06941985512475 EUDAMED06941985512550 EUDAMED06941985512529 EUDAMED06941985512536 EUDAMED06941985512581 EUDAMED06941985512352 EUDAMED06941985512420 EUDAMED06941985512307 EUDAMED06941985512697 EUDAMED06941985512505 EUDAMED06941985512376 EUDAMED06941985512314 EUDAMED06941985512567 EUDAMED06941985512628 EUDAMED06941985512666 EUDAMED06941985512338 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
Category: Orthodontic retainer
Orthodontic Elastics by Hangzhou DTC Medical Apparatus Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic retainer.
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- Stainless Steel Spring — American Orthodontics · Class IIa
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 (21)
- EUDAMED b96db8e1-b6a7-4803-ae46-f6d6bee074fa 61 fields · synced Oct 5, 2026
- EUDAMED a1e0684d-c83d-4793-81c4-d939d1c1e7b4 61 fields · synced May 16, 2026
- EUDAMED 473f248d-9130-4752-9e17-a63f1e1f6e4b 61 fields · synced May 16, 2026
- EUDAMED 8ce81597-d475-4de3-a918-3f520cf76b6e 61 fields · synced May 16, 2026
- EUDAMED 62dc816e-bd98-4019-9891-6f5e600d9365 61 fields · synced May 16, 2026
- EUDAMED 5b70137f-174e-4437-b720-7049d17e7e31 61 fields · synced May 16, 2026
- EUDAMED 7eef1c24-2344-44ad-a7f9-8a33fa8f3068 61 fields · synced May 17, 2026
- EUDAMED 6f4f07c1-db57-4a6e-9822-3f97d9d87cec 61 fields · synced May 17, 2026
- EUDAMED ad56cf45-caff-4f7c-96e7-90e105c1c9e4 61 fields · synced May 17, 2026
- EUDAMED e12e2f9b-c661-454f-9479-d397cff548bb 61 fields · synced May 17, 2026
- EUDAMED a118449d-08c9-4705-b0a0-7f1fabbd6fd0 61 fields · synced May 17, 2026
- EUDAMED 8266851e-69ce-4acb-a524-d5ea328f15c1 61 fields · synced May 18, 2026
- EUDAMED 0af7625e-7da2-4e39-bdea-d74559d827e5 61 fields · synced May 18, 2026
- EUDAMED 81e35127-7c65-473c-8360-12e9facc4b97 61 fields · synced May 18, 2026
- EUDAMED c2a1bd50-f0a6-42fb-aae5-6e5e7607ac65 61 fields · synced May 18, 2026
- EUDAMED aeb04986-17e9-4c95-90ba-bc6883371a42 61 fields · synced May 18, 2026
- EUDAMED fcb4847e-7e99-4e77-8785-b6dc963f24b7 61 fields · synced May 18, 2026
- EUDAMED 181c6f12-d8ec-43c5-a071-907baf853265 61 fields · synced May 18, 2026
- EUDAMED 5bedf892-23dd-4066-a70d-907a89d41625 61 fields · synced May 18, 2026
- EUDAMED 6ff7073c-28b6-4959-95c7-bfae5b13ed64 61 fields · synced May 18, 2026
- EUDAMED 5dc2cace-e43c-48c2-9a7b-68b0fb5d29c1 61 fields · synced May 19, 2026