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Dr.Paleys Osteotomy System DRPBC-201

by Orthopediatrics Canada ULC

Ref DRPBC-201Model BEAM COMPASS

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7540194DRP-BCMPVF Basic UDI-DI 07540194015976UDI-DIDate29 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number07540194015976 UDI-DI Date11 Sep 2024ListedStatusListed 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  • Withdrawn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
Dr Paley’s Osteotomy System EUDAMED
Dr.Paleys Osteotomy System GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
DRPBC-201, BEAM COMPASS
Primary DI / UDI-DI
07540194015976
Basic UDI-DI
7540194DRP-BCMPVF
FDA Product Code
LXH
EMDN Code
L0923 Orthopaedics surgical measurers, reusable
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Other devices from Orthopediatrics Canada ULC

See all devices from Orthopediatrics Canada ULC →

Properties

  • Single Use
  • Reusable
  • Measuring Function
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (18)

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