Identity
- Trade Name
- ENT Diagnostic Set EUDAMED
- Device Name
- ENT Diagnostic Set EUDAMED
- Model / Reference
- 01-155 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004479762 EUDAMED
- Basic UDI-DI
- 89640031763407R EUDAMED
- EMDN Code
- L1699 DIAGNOSTIC INSTRUMENTS, REUSABLE- OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Formed Surgical Instruments — 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 | 89640031763407R | Class I | Active |
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Manufacturer
- Manufacturer
- Formed Surgical Instruments
- EUDAMED SRN
- PK-MF-000011695
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 7fda9582-e994-4c3d-bc1f-773d5373e48a 61 fields · synced Jun 18, 2026