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Perla® Tl Fixed Probe Ball Handle

by Spineart SA EUDAMEDGUDID

Active European Union

Ref HAN-FI BA 50-N

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1764045086SRI00REUSIN1R3E Basic UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640221373038 UDI-DIDate7 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Perla® Tl Fixed Probe Ball Handle EUDAMED
Perla ® Tl GUDID
Generic Name
Surgical instrument handle, torque-limiting
Device Name
SURGICAL REUSABLE INSTRUMENTS Ir
Model / Reference
HAN-FI BA 50-N
Primary DI / UDI-DI
07640221373038
Basic UDI-DI
1764045086SRI00REUSIN1R3E
Direct Marketing DI
07640221373038
FDA Product Code
LXH
EMDN Code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN Term
Surgical instrument handle, torque-limiting
Device Class
Class I
Regulation Number
888.4540
Market of Registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CH-MF-000015664
Authorised representative
Alpes CN SAS FR-AR-000013241

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Properties

  • Sterile YesEUDAMEDNoGUDID
  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No