Identity
- Trade Name
- Aligner Chewies EUDAMED
- Device Name
- Aligner Chewies EUDAMED
- Model / Reference
- 81-21201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978726483824 EUDAMED
- Basic UDI-DI
- 69787264881-212014C EUDAMED
- Direct Marketing DI
- 06978726483824 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 Jiangsu Yabaobao Medical Instrument 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 | 69787264881-212014C | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Yabaobao Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000048665
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 2073f760-03e3-4e3f-bea0-529b49b82136 61 fields · synced Jul 16, 2026