Identity
- Trade Name
- Radial Runway EUDAMEDRadial Runway Base Assembly FDA UDI
- Generic Name
- Arm procedure positioner, reusable FDA UDI
- Device Name
- Radial Runway Base Assembly FDA UDI
- Model / Reference
- RRU-00008 EUDAMEDRRU-0008 EUDAMEDFDA UDI
- Description
- Radial Runway Base Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811331019162 EUDAMEDFDA UDI
- Basic UDI-DI
- 081133101RRU-0008ZQ EUDAMED
- FDA Product Code
- BWN FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Arm procedure positioner, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Radial Runway by Tz Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081133101RRU-0008ZQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- TZ Medical inc
- EUDAMED SRN
- US-MF-000027311
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED f5414a5f-360e-4d13-b9d7-a3548be5b047 61 fields · synced Oct 6, 2026
- FDA UDI a81d7aab-f2d1-404e-8c86-058f8ab8fd92 33 fields · synced May 22, 2026