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Opencast
EUDAMEDClass I (EU MDR)
Ref 6Model CM-03, CM-04, CM-05, CM-06, CM-07, CM-08, SA-S, SA-M, SL-S, SL-M, SL-L
by openM inc.
Identity
- Device Name
- OPENCAST EUDAMED
- Model / Reference
- CM-03, CM-04, CM-05, CM-06, CM-07, CM-08, SA-S, SA-M, SL-S, SL-M, SL-L EUDAMED6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800109800066 EUDAMED
- Basic UDI-DI
- 88001098OMBT EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I 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: Cotton wool roll, sterile
Opencast by openM inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 88001098OMBT | Class I | Active |
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Manufacturer
- Manufacturer
- openM inc.
- EUDAMED SRN
- KR-MF-000011553
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 60119bb3-9a09-42f0-80bb-a14c8b87337d 61 fields · synced Jun 19, 2026