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Olympus PS-0021EJDA

by Gyrus Acmi, Inc.

Ref PS-0021EJDA

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0821925000125A Basic UDI-DI 00821925045224UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925045224 UDI-DI Date8 May 2026ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Olympus
Generic Name
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Device Name
PowerSeal electrosurgical handpiece
Model / Reference
PS-0021EJDA
Primary DI / UDI-DI
00821925045224 EUDAMED
00821925045217 GUDID
Basic UDI-DI
0821925000125A
Unit of Use DI
00821925045217
510(k) Number
FDA Product Code
GEI
EMDN Code
K0201010502 Laparoscopic and thoracoscopic electrosurgery handpieces, single-use
GMDN Term
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925045224
GUDID
00821925045217
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No