Identity
- Trade Name
- TruPose Head Adjuster EUDAMED
- Device Name
- TruPose Head Adjuster EUDAMED
- Model / Reference
- 91710 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850019946680 EUDAMED
- Basic UDI-DI
- 0850019946HEADHOLDERTU EUDAMED
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
TruPose Head Adjuster by Standard Imaging, 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 | 0850019946HEADHOLDERTU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Standard Imaging, Inc.
- EUDAMED SRN
- US-MF-000009855
- Authorised Representative
- Hoff & Lowendahl AB SE-AR-000001888
Sources (1)
- EUDAMED 389eca12-ffec-4730-847b-b441365d18c3 61 fields · synced Jul 9, 2026