Identity
- Device Name
- Patient Positioner EUDAMED
- Model / Reference
- PP-16MMs EUDAMED
Identifiers
- Primary DI / UDI-DI
- 60099003608056 EUDAMED
- Basic UDI-DI
- 60099003608016KR EUDAMED
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Croatia 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
Patient Positioner by Blue White Capital Pty (Ltd) — 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 | 60099003608016KR | Class I | Active |
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Manufacturer
- Manufacturer
- Blue White Capital Pty (Ltd)
- EUDAMED SRN
- ZA-MF-000052565
- Authorised Representative
- TNMC Devices Llc HR-AR-000019582
Sources (1)
- EUDAMED 3c9ef02d-62eb-4afa-959b-58a3d7a6b3ed 61 fields · synced Jul 9, 2026