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PACE Model 101 bipolar OSYPKA MEDICAL

by Osypka Medical GmbH

Ref 2004Model PACE 101

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04260451441197 Basic UDI-DI 04260451441197UDI-DIDate8 Sep 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
PACE 101, 2004
Primary DI / UDI-DI
04260451441197
Basic UDI-DI
B-04260451441197
EMDN Code
C020299 Cardiac temporary stimulation devices (with or without active substances) - other
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006000

From the manufacturer

Manufacturer's product page: PACE MODEL 101

Other devices from Osypka Medical GmbH

See all devices from Osypka Medical GmbH →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No