Identity
- Trade Name
- ENT DIAGNOSTIC SET EUDAMED
- Device Name
- ENT DIAGNOSTIC SET EUDAMED
- Model / Reference
- FMO-001-9200-2095.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004012525 EUDAMED
- Basic UDI-DI
- 8964003248PS0195 EUDAMED
- EMDN Code
- L1699,Z12149099 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
Ent Diagnostic Set 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 | 8964003248PS0195 | 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 5f087563-4211-4a18-8eea-e8e455c604bc 61 fields · synced Jul 29, 2026