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High Capacity Vacuum Pump + Hose +Connector 115V - not UL Listed or CSA Approved

by Orfit Industries

Ref 18076/115Model Vacuum pump, Hose, Connector

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 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5420028700555B Basic UDI-DI 05420028761601UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05420028761601 UDI-DI Date15 Apr 2026ListedStatusListed 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 22 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  • Withdrawn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
High Capacity Vacuum Pump + Hose +Connector 115V - not UL Listed or CSA Approved EUDAMED
Orfit GUDID
Generic Name
Vacuum-mould patient positioning system
Device Name
Vacuum pumps
Model / Reference
Vacuum pump, Hose, Connector, 18076/115
Primary DI / UDI-DI
05420028761601
Basic UDI-DI
5420028700555B
510(k) Number
FDA Product Code
IYE
EMDN Code
Z11010180 Linear accelerators - hardware accessories
GMDN Term
Vacuum-mould patient positioning system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.5050
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
BE-MF-000007872

Other devices from Orfit Industries

See all devices from Orfit Industries →

Properties

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