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BlueBAG Rectangular 1000x1500 mm/80 L

by 3C-Medical Intelligence GmbH

Ref P10104-143

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number04056719BUDI0000000001HU Basic UDI-DI 04056719000585UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04056719000585 UDI-DI Date23 Aug 2016ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
BlueBAG Rectangular 1000x1500 mm/80 L EUDAMED
BodyFIX GUDID
Generic Name
Vacuum-mould patient positioning system
Device Name
BodyFIX, BlueBAG
Model / Ref / Catalog
P10104-143
Primary DI / UDI-DI
04056719000585
Basic UDI-DI
04056719BUDI0000000001HU
Direct Marketing DI
04056719000585
510(k) Number
FDA Product Code
IYE
EMDN Code
V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)
GMDN Term
Vacuum-mould patient positioning system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.5050
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000023763

Other devices from 3C-Medical Intelligence GmbH

See all devices from 3C-Medical Intelligence GmbH →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No