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Berchtold GmbH & Co. KG

Active in EUDAMED

Germanyfrom SRN EUDAMED FDA SRN DE-MF-000005446 FEI 3006125657

Devices
5
Registrations
EUDAMEDFDA
FDA recalls
7

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls

Catalogue5

Newest first, rows 1-5 of 5

  • Operon Ref OPE10000

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Oculan Ref COMM0003

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Oculan Ref COMM0004

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Oculan Ref COMM0001

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Oculan Ref COMM0002

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Company details

EUDAMED SRN
DE-MF-000005446
FDA FEI number
3006125657
EU VAT number
DE 142932906
EUDAMED status
Active
EUDAMED registered name
Berchtold GmbH & Co. KG
Registered address
25, Ludwigstaler Strasse, 78532, Tuttlingen, Germany
PRRC contact
Stefan Christ(public in EUDAMED)

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2016

    • 19 Apr 2016 Z-1925-2016 Class II Terminated The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-ray. Distribution: Nationwide Distribution

  • 2015

    • 23 Sep 2015 Z-0154-2016 Class II Terminated During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work properly due to fluid intrusion within the control switches and/or the control board assembly. Distribution: Worldwide Distribution - US (nationwide), Canada, and Germany

  • 2013

    • 12 Mar 2013 Z-1488-2013 Class II Terminated The firm received complaints for unintended movements. Distribution: Nationwide Distribution

  • 2012

    • 10 Jul 2012 Z-2148-2012 Class III Terminated Defective camera: There is a possibility that the connection of the wires to the connector may become loose, causing image distortion or loss. Distribution: Nationwide Distribution including FL, MI, MS, and NH.
    • 16 Apr 2012 Z-2168-2013 Class II Terminated Table was not lowering. Distribution: USA Nationwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, HI.IL, IA, KY, LA, MD, MA, MI, MN, MS, NH, NJ,…
      Full distribution text USA Nationwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, HI.IL, IA, KY, LA, MD, MA, MI, MN, MS, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WI and including Canada.

  • 2009

    • 16 Nov 2009 Z-0591-2011 Unclassified (pre-2012) Terminated A mechanical failure of a welded joint within the spring Arm may result in the rapid drop of a monitor to the mechanical stop. Distribution: Worldwide Distribution: Throught the U.S,.and the countries of Canada and Germany Submission number: K922836
    • 2 Feb 2009 Z-1123-2009 Unclassified (pre-2012) Terminated Difficulty in pressing the button needed to release a bed part resulted in an injury to a caregiver's finger which became stuck in metal latch under the gas cylinder of the bed piece. Distribution: Worldwide Distribution -- US and Canada.

Frequently asked questions

How many devices does Berchtold GmbH & Co. KG have in the registry?

The registry currently lists 5 devices for Berchtold GmbH & Co. KG. Devices recorded under merged duplicate company entries are counted once.

Which registries list Berchtold GmbH & Co. KG's devices?

Among its 5 most recently registered devices, Berchtold GmbH & Co. KG has devices listed in EUDAMED (5 devices).

What risk classes do Berchtold GmbH & Co. KG's devices fall under?

Among its 5 most recently registered devices, the classes recorded for Berchtold GmbH & Co. KG's devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for Berchtold GmbH & Co. KG?

FDA recall records list 7 recalls initiated by Berchtold GmbH & Co. KG, the most recent initiated on 19 Apr 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Berchtold GmbH & Co. KG in the registry?

The most recently registered devices listed for Berchtold GmbH & Co. KG include Operon and Oculan.

Generated automatically from registry data and not verified by a human reviewer.