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Primeline Pro JP114

by Aesculap, Inc.

Ref JP114

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 Number4039239000001135ZT Basic UDI-DI 04046964860188UDI-DIDate2 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04046964860188 UDI-DI Date21 May 2018ListedStatusListed 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  • Withdrawn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
PRIMELine® PRO EUDAMED
Primeline Pro GUDID
Generic Name
Device sterilization/disinfection container, reusable
Device Name
PRIMELINE PRO container lid
Model / Ref / Catalog
JP114
Primary DI / UDI-DI
04046964860188
Basic UDI-DI
4039239000001135ZT
Direct Marketing DI
04046964860188
FDA Product Code
KCT
EMDN Code
S010401 Trays, baskets, tubs for sterilisation and their components
GMDN Term
Device sterilization/disinfection container, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.6850
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
GUDID
Class II

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

  • Over-the-Counter
  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No