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Adtec Monopolar

by Aesculap AG 2 variants

Ref PM957R, PO738R, PM614R

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000002982L Basic UDI-DI Date2 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653208777 UDI-DI Date23 Sep 2016ListedStatusListed 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  • Withdrawn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
Adtec Monopolar EUDAMED
Aesculap GUDID
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Surgical instrument handle, non-torque-limiting
Device Name
AdTec axial ring handle
AdTec scissors non-sterile
AdTec tissue grasp. fcps IIb non-sterile
Model / Ref / Catalog
PM957R, PM614R, PO738R
Primary DI / UDI-DI
04038653208777, 04038653182732, 04038653290055
Basic UDI-DI
40392390000002982L, 40392390000005372F, 403923900000053429
Direct Marketing DI
04038653208777
FDA Product Code
GEI, GCJ, DXC
EMDN Code
L1203, L180202, L180402
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Surgical instrument handle, non-torque-limiting
Device Class
Class I EUDAMED
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400, 876.1500, 870.4450
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005504

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • 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
  • Expiration Date: No
  • Manufacturing Date: No