Narrow Head Section
Part of a family of 8 devices: see the family page
Ref 08-075-00
Narrow Head Section (08-075-00) is a Class I device made by Mizuho Corporation, registered in EUDAMED on 2 Sep 2025 (Basic UDI-DI 49463290208024UE) and listed in FDA GUDID since 5 Sep 2025 (UDI-DI 04946329385847), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number04946329385847 | Date5 Sep 2025 | StatusListed |
| European Union | CE/MDR EUDAMED | Number49463290208024UE 04946329385847 | Date2 Sep 2025 | StatusActive |
Official records
- EUDAMED public site 49463290208024UE
- AccessGUDID record 04946329385847
Across registries
- EUDAMED Basic UDI-DI 49463290208024UE registered 2 Sep 2025 Active
- FDA GUDID UDI-DI 04946329385847 listed 5 Sep 2025 Listed
Timeline
- Registered EUDAMED 49463290208024UE
- Listed FDA GUDID 04946329385847
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Head/neck procedure positioner
- Model / Ref / Catalog
- 08-075-00
- Primary DI / UDI-DI
- 04946329385847
- Basic UDI-DI
- 49463290208024UE
- Direct marketing DI
- 04946329385847
- FDA product code
- GDC
- EMDN code
- Z12011280 Patient positioning instruments - hardware accessories
- GMDN term
- Head/neck procedure positioner
- Device class
- Class I
- Regulation number
- 878.4960
- EU registration type
- Standard device
- EU market of registration
- Romania
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 254 Millimeter
Manufacturer details
- EUDAMED SRN
- JP-MF-000019215
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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