Identity
- Trade Name
- FMO-001-8200-1090 EUDAMED
- Device Name
- DERMATOSCOPE EUDAMED
- Model / Reference
- DERMATOSCOPE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004012587 EUDAMED
- Basic UDI-DI
- 8964003248DM045R EUDAMED
- EMDN Code
- Z12040108 DERMATOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Fmo-001-8200-1090 by SG Manufacturers — 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 | 8964003248DM045R | Class I | Active |
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Manufacturer
- Manufacturer
- SG Manufacturers
- EUDAMED SRN
- PK-MF-000007106
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 8b444d7b-578b-4e4d-aede-cb409d3a7f8b 61 fields · synced Aug 3, 2026