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Vacuum Cushion CT Open Headrest 110x55cm

by Guangdong Meicen Medical Equipment Co., Ltd.

Ref RC-E4004

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06977071938126 UDI-DI Date26 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697707193800NH Basic UDI-DI Date28 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Vacuum Cushion CT Open Headrest 110x55cm EUDAMED
Meicen GUDID
Generic Name
Vacuum-mould patient positioning system
Device Name
Vacuum Cushions
Model / Reference
RC-E4004
Primary DI / UDI-DI
06977071938126, 06977071938331
Basic UDI-DI
697707193800NH
FDA Product Code
IWE
EMDN Code
Z119099 Various bioimaging and radiotherapy instruments - other
GMDN Term
Vacuum-mould patient positioning system
Device Class
Class I
Regulation Number
892.5780
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000039245
Authorised representative
OSMUNDA Medical Technology Service GmbH DE-AR-000009285

Other devices from Guangdong Meicen Medical Equipment Co., Ltd.

See all devices from Guangdong Meicen Medical Equipment Co., Ltd. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No