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Pivoting Center Blade Holder, 130mm

by TeDan Surgical Innovations, Inc.

Ref VPR0203

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8430591BLADEHANDLE3V Basic UDI-DI 00843059126105UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843059126105 UDI-DI Date2 Mar 2023ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
Pivoting Center Blade Holder, 130mm EUDAMED
Tsi GUDID
Generic Name
Surgical instrument handle, non-torque-limiting
Device Name
Blade Handle
Model / Reference
VPR0203
Primary DI / UDI-DI
00843059126105
Basic UDI-DI
8430591BLADEHANDLE3V
Direct Marketing DI
00843059126105
FDA Product Code
LXH
EMDN Code
L99 Surgical instruments, reusable - other
GMDN Term
Surgical instrument handle, non-torque-limiting
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

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

Related devices

Category: Surgical retraction system, reusable

Other devices from TeDan Surgical Innovations, Inc.

See all devices from TeDan Surgical Innovations, Inc. →

Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No