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Halyard 49848

by GRI Medical & Electronic Technology Co., Ltd.

Part of a family of 130 devices: see the family pagePart of a family of 540 devices: see the family page

Ref 49848

Halyard 49848 is a device classified as Class I in the EU and Class II in the US made by GRI Medical & Electronic Technology Co., Ltd., registered in EUDAMED on 9 Feb 2026 (Basic UDI-DI 69319181F072LA) and listed in FDA GUDID since 19 Jul 2024 (UDI-DI 16931918188591), 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 Number69319181F072LA Basic UDI-DI 16931918188591UDI-DIDate9 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number16931918188591 UDI-DI Date19 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 69319181F072LA registered 9 Feb 2026 Active
  • FDA GUDID UDI-DI 16931918188591 listed 19 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 16931918188591
  2. Registered EUDAMED 69319181F072LA

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  • Withdrawn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
Halyard
Generic name
Patient surgical drape, single-use
Device name
Surgical Drapes
Equipment Covers
Model / reference
49848
Primary DI / UDI-DI
16931918188591
Basic UDI-DI
69319181F072LA, 69319181F008KZ
FDA product code
PUI
EMDN code
T020199, T030101
GMDN term
Patient surgical drape, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4370
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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: Patient surgical drape, single-use

Similar devices in this category

Other devices filed under SURGICAL DRAPES - OTHER.

Other devices from GRI Medical & Electronic Technology Co., Ltd.

See all devices from GRI Medical & Electronic Technology Co., Ltd. →

Properties

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