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499750004

by Richard Wolf GmbH

Ref 49975.0004Model 10000201376

499750004 (49975.0004) is a device classified as Class IIa in the EU and Class I in the US made by Richard Wolf GmbH, registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI B-04055207050590) and listed in FDA GUDID since 17 Feb 2022 (UDI-DI 04055207050590), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04055207050590 Basic UDI-DI 04055207050590UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207050590 UDI-DI Date17 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207050590 registered 8 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207050590 listed 17 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207050590
  2. Registered EUDAMED B-04055207050590

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Orthopaedic bur, single-use
Device name
Arthroscopic burrs and resectors
Model / Ref / Catalog
10000201376, 49975.0004, 499750004
Primary DI / UDI-DI
04055207050590
Basic UDI-DI
B-04055207050590
FDA product code
HWE
EMDN code
K030204 Arthroscopy burs, single-use
GMDN term
Orthopaedic bur, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 4.5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201376
49975.0004
GUDID
499750004
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Orthopaedic bur, single-use

Similar devices in this category

Other devices filed under ARTHROSCOPY BURS, SINGLE-USE.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

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