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Drape Support

by Adept Medical Ltd

Ref AM1000B

Drape Support (AM1000B) is a Class I device made by Adept Medical Ltd, registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 942190518741AM1000B56) and listed in FDA GUDID since 15 Feb 2024 (UDI-DI 09421905187411), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number942190518741AM1000B56 Basic UDI-DI 09421905187411UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09421905187411 UDI-DI Date15 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 942190518741AM1000B56 registered 23 Jun 2026 Active
  • FDA GUDID UDI-DI 09421905187411 listed 15 Feb 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 09421905187411
  2. Registered EUDAMED 942190518741AM1000B56

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  • Withdrawn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
Drape Support EUDAMED
Adept Medical Drape Support GUDID
Generic name
Bedding support
Model / Ref / Catalog
AM1000B, B
Primary DI / UDI-DI
09421905187411
Basic UDI-DI
942190518741AM1000B56
FDA product code
BWN
EMDN code
Z11039099 Various radiodiagnostic and interventional instruments – other
GMDN term
Bedding support
Device class
Class I
Regulation number
878.4950
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Liquid Chemical

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AM1000B
GUDID
B
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 09421905187411: EUDAMED states No, FDA GUDID states Yes.

Manufacturer details

EUDAMED SRN
NZ-MF-000003374
Authorised representative
Qualrep Services B.V. NL-AR-000000537

Related devices

Category: Electromagnetic surgical navigation device tracking system

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER.

Other devices from Adept Medical Ltd

See all devices from Adept Medical Ltd →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)