Identity
- Trade Name
- Radial Arm Board EUDAMEDRadial Arm Board Straps EUDAMED
- Model / Reference
- CZ-400 EUDAMEDTVA-MC-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811331011661 EUDAMED00811331012972 EUDAMED
- Basic UDI-DI
- 081133101CZ-400H7 EUDAMED081133101TVA-MC-25A EUDAMED
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Radial Arm Board by Tz 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 | 081133101CZ-400H7 | Class I | Active |
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Manufacturer
- Manufacturer
- TZ Medical inc
- EUDAMED SRN
- US-MF-000027311
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 9471663c-42df-456a-bc6a-bb2361088efd 61 fields · synced Oct 7, 2026
- EUDAMED 379d0f4b-80ec-4243-a2b3-a341310d7fb2 61 fields · synced May 19, 2026