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Clear Bag Decanter

by Advance Medical Designs, Inc.

Ref 10-110

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8483400010-110L8 Basic UDI-DI 00848340000041UDI-DIDate24 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00848340000041 UDI-DI Date15 Sep 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.

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  • Withdrawn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
Fluid transfer set, general-purpose
Device Name
Clear Bag Decanter
Model / Reference
10-110
Primary DI / UDI-DI
00848340000041
Basic UDI-DI
8483400010-110L8
FDA Product Code
KPE
EMDN Code
A0699 Drainage and fluid collection devices - other
GMDN Term
Fluid transfer set, general-purpose
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5025
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
US-MF-000009790
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Advance Medical Designs, Inc.

See all devices from Advance Medical Designs, Inc. →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No