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35-70-255

by VBM Medizintechnik GmbH

Ref 35-70-255

35-70-255 is a Class I device made by VBM Medizintechnik GmbH, registered in EUDAMED on 18 Mar 2026 (Basic UDI-DI 42501056-1.5.10-NR) and listed in FDA GUDID since 25 Aug 2020 (UDI-DI 04250105601473), active as of 23 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42501056-1.5.10-NR Basic UDI-DI 04250105601473UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250105601473 UDI-DI Date25 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42501056-1.5.10-NR registered 18 Mar 2026 Active
  • FDA GUDID UDI-DI 04250105601473 listed 25 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250105601473
  2. Registered EUDAMED 42501056-1.5.10-NR

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  • Withdrawn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
Fixation Tape; for adult
Generic name
Tracheostomy tube neck holder, reusable
Device name
Face Masks - Acc. Face Masks
Model / reference
35-70-255
Primary DI / UDI-DI
04250105601473
Basic UDI-DI
42501056-1.5.10-NR
FDA product code
BTK
EMDN code
R01038099 Endotracheal tubes - accessories not included in other classes
GMDN term
Tracheostomy tube neck holder, reusable
Device class
Class I
Regulation number
868.5560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 04250105601473: EUDAMED states Yes, FDA GUDID states No.

Related devices

Category: Tracheostomy tube neck holder, reusable

Similar devices in this category

Other devices filed under ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from VBM Medizintechnik GmbH

See all devices from VBM Medizintechnik GmbH →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)