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Gauze balls 12x12cm, 1x5pcs, sterile
EUDAMEDClass I (EU MDR)
Ref 28012
by PANEP s.r.o.
Identity
- Trade Name
- Gauze balls 12x12cm, 1x5pcs, sterile EUDAMED
- Device Name
- PANEP STERISET ABSORPCE - Tampon stáčený z gázy EUDAMED
- Model / Reference
- 28012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592323040136 EUDAMED
- Basic UDI-DI
- 8592323PSATAMPSTACGAZAZW EUDAMED
- EMDN Code
- M020199 COTTON GAUZES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Gauze balls 12x12cm, 1x5pcs, 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 | 8592323PSATAMPSTACGAZAZW | Class I | Active |
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Manufacturer
- Manufacturer
- PANEP s.r.o.
- EUDAMED SRN
- CZ-MF-000033142
Sources (1)
- EUDAMED 2e22b1ac-0424-4606-9cc4-dc6ba8220733 61 fields · synced Jul 28, 2026