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ORTHO-FIX Plaster of Paris Bandage 15cmx3m
EUDAMEDClass I (EU MDR)
Ref 1323500105
Identity
- Trade Name
- ORTHO-FIX Plaster of Paris Bandage 15cmx3m EUDAMED
- Device Name
- PORÉZNÍ SÁDROVÁ OBINADLA / POROUS PLASTER OF PARIS BANDAGE EUDAMED
- Model / Reference
- 1323500105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 28591454005759 EUDAMED
- Basic UDI-DI
- 8591454doc010M2 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - 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
Category: Hand/finger splint, reusable
ORTHO-FIX Plaster of Paris Bandage 15cmx3m by BATIST Medical a.s. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand/finger splint, reusable.
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- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
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 | 8591454doc010M2 | Class I | Active |
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Manufacturer
- Manufacturer
- BATIST Medical a.s.
- EUDAMED SRN
- CZ-MF-000023038
Sources (1)
- EUDAMED b5ce4bd9-61b6-4326-bc2c-772631f5a4b0 61 fields · synced Jun 19, 2026