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Aesculap PO028R

by Aesculap, Inc.

Part of a family of 56 devices: see the family page

Ref PO028R

Aesculap PO028R is a device classified as Class IIb in the EU and Class II in the US made by Aesculap, Inc., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 40392390000005372F) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04038653335800), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000005372F Basic UDI-DI 04038653335800UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653335800 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000005372F registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 04038653335800 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653335800
  2. Registered EUDAMED 40392390000005372F

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  • Withdrawn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
Adtec Monopolar EUDAMED
Aesculap GUDID
Generic name
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Device name
AdTec scissors non-sterile
Model / Ref / Catalog
PO028R
Primary DI / UDI-DI
04038653335800
Basic UDI-DI
40392390000005372F
FDA product code
KNF
EMDN code
L180202 Endoscopic electrosurgery scissors, reusable
GMDN term
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
884.4160
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Similar devices in this category

Other devices filed under ENDOSCOPIC ELECTROSURGERY SCISSORS, REUSABLE.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)