Identity
- Trade Name
- ORTHO-PAD Undercasting Padding 15cmx3m EUDAMED
- Device Name
- NESTERILNÍ POLSTROVACÍ OBVAZY POD SÁDRU / NON-STERILE PADDING BANDAGES UNDER GYPSUM EUDAMED
- Model / Reference
- 1320105005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591454014009 EUDAMED
- Basic UDI-DI
- 8591454doc007MD EUDAMED
- EMDN Code
- M03030202 SKIN PROTECTIVE BANDAGES 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
ORTHO-PAD Undercasting Padding 15cmx3m 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 | 8591454doc007MD | Class I | Active |
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Manufacturer
- Manufacturer
- BATIST Medical a.s.
- EUDAMED SRN
- CZ-MF-000023038
Sources (1)
- EUDAMED 41726ac9-2d12-4a99-9c31-e50c66d24b54 61 fields · synced Jun 18, 2026