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Elbow, Long, Red

by TeDan Surgical Innovations, Inc.

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

Ref HS-0062

Elbow, Long, Red (HS-0062) is a Class I device made by TeDan Surgical Innovations, Inc., registered in EUDAMED on 5 Apr 2022 (Basic UDI-DI 8430591ARMF8) and listed in FDA GUDID since 21 Aug 2017 (UDI-DI 00843059109580), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8430591ARMF8 Basic UDI-DI 00843059109580UDI-DIDate5 Apr 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00843059109580 UDI-DI Date21 Aug 2017ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8430591ARMF8 registered 5 Apr 2022 Active
  • FDA GUDID UDI-DI 00843059109580 listed 21 Aug 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00843059109580
  2. Registered EUDAMED 8430591ARMF8

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  • Withdrawn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
Elbow, Long, Red EUDAMED
Tsi GUDID
Generic name
Surgical instrument assist arm system, manually-adjusted
Device name
Arm
Model / reference
HS-0062
Primary DI / UDI-DI
00843059109580
Basic UDI-DI
8430591ARMF8
Direct marketing DI
00843059109580
FDA product code
FWZ
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Surgical instrument assist arm system, manually-adjusted
Device class
Class I
Regulation number
878.4950
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000016933
Authorised representative
TeDan Surgical Innovations B.V. NL-AR-000002696

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from TeDan Surgical Innovations, Inc.

See all devices from TeDan Surgical Innovations, Inc. →

Properties

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