Identity
- Device Name
- Non Sterile Single Use Forceps EUDAMED
- Model / Reference
- FKS028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B978FKS0280K EUDAMED
- Basic UDI-DI
- ++B978FORCEPSNSSA3 EUDAMED
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Non Sterile Single Use Forceps by Franko Shehzad Surgico 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 | ++B978FORCEPSNSSA3 | Class I | Active |
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Manufacturer
- Manufacturer
- Franko Shehzad Surgico (Pvt) Ltd
- EUDAMED SRN
- PK-MF-000046363
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 1b140ef8-55b6-498c-b721-f47db600bd98 61 fields · synced Jun 18, 2026