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Unbranded 07-PK807

by Advance Medical Designs, Inc.

Ref 07-PK807

Unbranded 07-PK807 is a device classified as Class I in the EU and Class II in the US made by Advance Medical Designs, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 8483400007-PK807Q9) and listed in FDA GUDID since 4 Oct 2016 (UDI-DI 00848340003615), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8483400007-PK807Q9 Basic UDI-DI 00848340003615UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848340003615 UDI-DI Date4 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8483400007-PK807Q9 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00848340003615 listed 4 Oct 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848340003615
  2. Registered EUDAMED 8483400007-PK807Q9

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  • Withdrawn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
Unbranded
Generic name
Instrument/equipment drape, single-use, sterile
Model / reference
07-PK807
Primary DI / UDI-DI
00848340003615
Basic UDI-DI
8483400007-PK807Q9
FDA product code
JAA
EMDN code
T030199 Covers, instruments and equipment - other
GMDN term
Instrument/equipment drape, single-use, sterile
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1650
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

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

  • Supplied sterile UDI-DI 00848340003615: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 00848340003615: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Instrument/equipment drape, single-use, sterile

Similar devices in this category

Other devices filed under COVERS, INSTRUMENTS AND EQUIPMENT - OTHER.

Other devices from Advance Medical Designs, Inc.

See all devices from Advance Medical Designs, Inc. →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)