Identity
- Trade Name
- Orthoflex® EUDAMED
- Device Name
- ORTHOFLEX EUDAMED
- Model / Reference
- 72257-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04042809161731 EUDAMED
- Basic UDI-DI
- 40428094004034587 EUDAMED
- Unit of Use DI
- 04042809664201 EUDAMED
- EMDN Code
- M03030199 ELASTIC FIXING BANDAGES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Orthoflex® by Bsn Medical, 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 | 40428094004034587 | Class I | Active |
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Manufacturer
- Manufacturer
- BSN Medical Inc.
- EUDAMED SRN
- US-MF-000019174
- Authorised Representative
- BSN medical GmbH DE-AR-000005791
Sources (1)
- EUDAMED 9fecb3d9-9a76-4c79-b09d-12ac0f973839 61 fields · synced Jun 18, 2026