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6860

by Hans Rudolph Inc 4 variants

Part of a family of 70 devices: see the family page

Ref 201670Model 7600; 7700 Series

6860 (201670) is a device classified as Class IIa in the EU and Class II in the US made by Hans Rudolph Inc, registered in EUDAMED on 4 Aug 2025 (Basic UDI-DI 081713602691236BN) and listed in FDA GUDID since 5 Apr 2023 (UDI-DI 00874750005567), withdrawn as of 8 Nov 2026.

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081713602691236BN Basic UDI-DI 00874750005567UDI-DIDate4 Aug 2025RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00874750005567 UDI-DI Date5 Apr 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081713602691236BN registered 4 Aug 2025 Withdrawn
  • FDA GUDID UDI-DI 00874750005567 listed 5 Apr 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00874750005567
  2. Registered EUDAMED 081713602691236BN

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Generic name
CPAP/BPAP face mask, single-use
Device name
Oro-Nasal Mask
Model / Ref / Catalog
7600, 7700 Series, 201670, 6860
Primary DI / UDI-DI
00874750005567
Basic UDI-DI
081713602691236BN
FDA product code
BZD
EMDN code
R0301010201 Cpap masks
GMDN term
CPAP/BPAP face mask, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5905
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
7600; 7700 Series
201670
GUDID
6860
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: CPAP/BPAP face mask, single-use

Similar devices in this category

Other devices filed under CPAP MASKS.

Other devices from Hans Rudolph Inc

  • 7450 RV2 Mask

    Class I

  • 5530 3l Syringe

    Class I

  • 8431

    Class II

  • 7500

    Class II

See all devices from Hans Rudolph Inc →

Properties

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