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Biegler JR6060301

by Ningbo Albert Novosino Co., Ltd.

Part of a family of 34 devices: see the family page

Ref JR6060301Model 100ml, 200ml, 300ml, 500ml, 600ml, 700ml, 800ml, 1000ml, 1500ml, 2000ml, 3000ml, 4000ml, 5000ml

Biegler JR6060301 is a Class I device made by Ningbo Albert Novosino Co., Ltd., registered in EUDAMED on 17 Apr 2024 (Basic UDI-DI 697191946PICVH) and listed in FDA GUDID since 24 May 2024 (UDI-DI 06971919460664), active as of 22 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971919460664 UDI-DI Date24 May 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697191946PICVH Basic UDI-DI 06971919460664UDI-DIDate17 Apr 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697191946PICVH registered 17 Apr 2024 Active
  • FDA GUDID UDI-DI 06971919460664 listed 24 May 2024 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Registered EUDAMED 697191946PICVH
  2. Listed FDA GUDID 06971919460664

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  • Withdrawn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
Disposable Connecting Tube EUDAMED
Biegler GUDID
Generic name
Intravenous pressure infusor, manual, reusable
Device name
Pressure Infusion Cuff
Model / reference
JR6060301, 100ml, 200ml, 300ml, 500ml, 600ml, 700ml, 800ml, 1000ml, 1500ml, 2000ml, 3000ml, 4000ml, 5000ml
Primary DI / UDI-DI
06971919460664
Basic UDI-DI
697191946PICVH
FDA product code
KZD
EMDN code
A088001 Pressure infusion cuffs, single-use
GMDN term
Intravenous pressure infusor, manual, reusable
Device class
Class I
Regulation number
880.5420
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under PRESSURE INFUSION CUFFS, SINGLE-USE.

Other devices from Ningbo Albert Novosino Co., Ltd.

See all devices from Ningbo Albert Novosino Co., Ltd. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)