Identity
- Trade Name
- SOFTPORE 2,5cm x 18cm, 3 strips EUDAMED
- Device Name
- SOFTPORE EUDAMED
- Model / Reference
- 1220103123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08596222859912 EUDAMED
- Basic UDI-DI
- 8596222doc058N6 EUDAMED
- EMDN Code
- M050101 PLASTERS ON SPOOLS (ROLLS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
SOFTPORE 2, 5cm x 18cm, 3 strips by BATIST Medical Productions 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 | 8596222doc058N6 | Class I | Active |
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Manufacturer
- Manufacturer
- BATIST Medical Productions s.r.o.
- EUDAMED SRN
- CZ-MF-000023495
Sources (1)
- EUDAMED 334c84a6-c907-43f7-9173-9453a0d60ba3 61 fields · synced Jun 20, 2026