Identity
- Trade Name
- Orthodontic Kit EUDAMEDOrthodontic kit-net bag package,8pcs,with card pockage EUDAMED
- Device Name
- Orthodontic Kit EUDAMED
- Model / Reference
- 81-21001 EUDAMED81-10053 EUDAMED81-21002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978726483800 EUDAMED06978726484937 EUDAMED06978726484104 EUDAMED
- Basic UDI-DI
- 69787264881-2100142 EUDAMED
- Direct Marketing DI
- 06978726483800 EUDAMED06978726484937 EUDAMED06978726484104 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDGermany 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 Kit 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 | 69787264881-2100142 | 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 (3)
- EUDAMED 0c258d0e-56ed-4e62-a2fd-95350eb96695 61 fields · synced Jul 17, 2026
- EUDAMED 3e9b7157-ee46-45ea-92fa-4d69946118b8 61 fields · synced May 16, 2026
- EUDAMED 9e36362d-bb02-4841-b843-aadd97031eae 61 fields · synced May 16, 2026