Identity
- Trade Name
- Dental set EUDAMED
- Device Name
- Sterile Surgical Sets EUDAMED
- Model / Reference
- 150024 EUDAMED150023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974531730214 EUDAMED06974531730771 EUDAMED
- Basic UDI-DI
- 697453173005KK EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovenia EUDAMED
Clinical & Handling
Sterile
Yes
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
Dental set by Compass Surgical Innovations (Taizhou) 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 | 697453173005KK | Class I | Active |
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Manufacturer
- Manufacturer
- Compass Surgical Innovations (Taizhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020691
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 7f9d3aa6-796f-4022-b1d4-739c7ffccfdf 61 fields · synced Jul 17, 2026
- EUDAMED 7ff30d40-de09-4a1e-b5ab-ceec10e0e6bb 61 fields · synced Jul 17, 2026