Identity
- Device Name
- ENT EUDAMED
- Model / Reference
- F10-416 EUDAMEDF8-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G742F104160B EUDAMED+G742F81500D EUDAMED
- Basic UDI-DI
- ++G742ENTUK EUDAMED
- EMDN Code
- L149004 ENT SPECULUMS, REUSABLE EUDAMEDL149001 ENT CURETTES, REUSABLE 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 by Fairmount Industries Pvt Ltd — 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 | ++G742ENTUK | Class I | Active |
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Manufacturer
- Manufacturer
- Fairmount Industries Pvt Ltd
- EUDAMED SRN
- PK-MF-000044972
- Authorised Representative
- Maxcert Ltd XI-AR-000044423
Sources (2)
- EUDAMED 36d8a985-42ce-4c7d-a898-ed9a2c35b366 61 fields · synced Jul 9, 2026
- EUDAMED 083e9261-0077-40b2-be06-9f8dbdd61d44 61 fields · synced May 19, 2026