Identity
- Trade Name
- DentalReign Surgery Box EUDAMED
- Device Name
- Instrument Kits EUDAMED
- Model / Reference
- 7299911100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931704158275 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
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
DentalReign Surgery Box by DentalMaster(Xiamen) Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 72df0c46-c808-43a2-ad73-0074baa7d3f5 61 fields · synced Jun 20, 2026