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Stain Black
EUDAMEDClass IIa (EU MDR)
Ref Stain BlackModel LUNAR Universal Stain Shade A
by Medifive
Identity
- Model / Reference
- LUNAR Universal Stain Shade A EUDAMEDStain Black EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800136100634 EUDAMED
- Basic UDI-DI
- 88001361MF00043N EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Stain Black by Medifive — Class IIa — 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 | 88001361MF00043N | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medifive
- EUDAMED SRN
- KR-MF-000016709
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 7385b6a6-ca0a-47cc-964c-f749e03ce4ac 61 fields · synced Jun 17, 2026