Identity
- Device Name
- Chewie EUDAMED
- Model / Reference
- S414 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970870050034 EUDAMED
- Basic UDI-DI
- 697087005CHEWAAJH EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Chewie by Coral Healthcare Products Manufacturer 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 | 697087005CHEWAAJH | Class I | Active |
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Manufacturer
- Manufacturer
- Coral Healthcare Products Manufacturer Co., Ltd
- EUDAMED SRN
- CN-MF-000011818
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (1)
- EUDAMED 56b9af94-0031-4b2e-86fb-dc2553b4f78f 61 fields · synced Jun 18, 2026