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Ophthalmic drape 70x70cm, integral incise film, Fen.10x10cm, sterile
EUDAMEDClass I (EU MDR)
Ref 38481
by PANEP s.r.o.
Identity
- Trade Name
- Ophthalmic drape 70x70cm, integral incise film, Fen.10x10cm, sterile EUDAMED
- Device Name
- PANEP STERISET BARIERA - Rouška operační oční EUDAMED
- Model / Reference
- 38481 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592323007108 EUDAMED
- Basic UDI-DI
- 8592323PSBROPEROCNIJG EUDAMED
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
Ophthalmic drape 70x70cm, integral incise film, Fen.10x10cm, sterile by PANEP s.r.o. — 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 | 8592323PSBROPEROCNIJG | Class I | Active |
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Manufacturer
- Manufacturer
- PANEP s.r.o.
- EUDAMED SRN
- CZ-MF-000033142
Sources (1)
- EUDAMED f84e022d-c92b-4ab9-a95b-69ba4ddccec6 61 fields · synced Jul 27, 2026