Identity
- Device Name
- Orthodontic Kit EUDAMED
- Model / Reference
- OK1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979853490556 EUDAMED
- Basic UDI-DI
- 697985349OK001TJ EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Changzhou Shengkang 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 | 697985349OK001TJ | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Shengkang Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000035829
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 33e6ba4b-eb11-4d4b-a5db-45eb3428541d 61 fields · synced Jun 17, 2026