Identity
- Trade Name
- Edentulous Basic Instrument Box EUDAMED
- Device Name
- Instrument Kits EUDAMED
- Model / Reference
- 7212790100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941812579107 EUDAMED
- Basic UDI-DI
- 6973122CK040010118U EUDAMED
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Edentulous Basic Instrument Box by DentalMaster(Xiamen) Medical Technology 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 | 6973122CK040010118U | Class I | Active |
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Manufacturer
- Manufacturer
- DentalMaster(Xiamen) Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000022723
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 6a96dcfd-abee-4fba-92b2-9813c291fcf7 61 fields · synced Jun 18, 2026