Identity
- Trade Name
- SOFTPORE Non woven Tape 2,5cmx9,15m EUDAMED
- Device Name
- NESTERILNÍ NÁPLASTI / NON-STERILE PLASTERS EUDAMED
- Model / Reference
- 1320103112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591454003195 EUDAMED
- Basic UDI-DI
- 8591454doc008MF EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER 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 Non woven Tape 2, 5cmx9, 15m by BATIST Medical a.s. — 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 | 8591454doc008MF | Class I | Active |
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Manufacturer
- Manufacturer
- BATIST Medical a.s.
- EUDAMED SRN
- CZ-MF-000023038
Sources (1)
- EUDAMED 016414be-5f8b-47d0-a4b7-df92d915529e 61 fields · synced Jun 17, 2026