Skip to content

Glide 94001-8

by Infinite Biomedical Technologies LLC

Ref 94001-8Model Glide - For Motion Control Standard Wrist or Ottobock 10S17 Wrist Configuration

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850004850886 UDI-DI Date20 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number850004850GLIDE4C Basic UDI-DI 00850004850886UDI-DIDate25 Feb 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Glide
Generic Name
Myoelectric hand prosthesis
Model / Reference
94001-8, Glide - For Motion Control Standard Wrist or Ottobock 10S17 Wrist Configuration
Primary DI / UDI-DI
00850004850886
Basic UDI-DI
850004850GLIDE4C
510(k) Number
FDA Product Code
GXY, IQZ
EMDN Code
Y240918 Control sensors
GMDN Term
Myoelectric hand prosthesis
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1320, 890.3420
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K240884)

Other devices from Infinite Biomedical Technologies LLC

See all devices from Infinite Biomedical Technologies LLC →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No