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Opencast
EUDAMEDClass I (EU MDR)
Ref 15Model 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 EUDAMED15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800109800240 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
Opencast by openM inc. — 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 | 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 08148380-7484-45e6-bc2a-c03ba90a32de 61 fields · synced Jun 18, 2026