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Unbranded 102NS

by Advance Medical Designs, Inc.

Ref 102NS

Unbranded 102NS 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 84834000102NS4T) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00848340005190), 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 Number84834000102NS4T Basic UDI-DI 00848340005190UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848340005190 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 84834000102NS4T registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00848340005190 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848340005190
  2. Registered EUDAMED 84834000102NS4T

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  • Withdrawn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
Model / reference
102NS
Primary DI / UDI-DI
00848340005190
Basic UDI-DI
84834000102NS4T
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 registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
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 00848340005190: 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: Fluid transfer set, general-purpose

Similar devices in this category

Other devices filed under DRAINAGE AND FLUID COLLECTION DEVICES - OTHER.

Other devices from Advance Medical Designs, Inc.

See all devices from Advance Medical Designs, Inc. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)