EUDAMED registration 00841019119891Yes

DISPOSABLE BIPOLAR FORCEPS, 7" (17.8cm), COMFORT GRIP NON STICK IRRIGATING 1.0mm TIP, INSULATED

Name: DISPOSABLE BIPOLAR FORCEPS, 7" (17.8cm), COMFORT GRIP NON STICK IRRIGATING 1.0mm TIP, INSULATED — EUDAMED registration 00841019119891
Creator: Kirwan Surgical Products LLC
Keywords: DISPOSABLE BIPOLAR FORCEPS, 7" (17.8cm), COMFORT GRIP NON STICK IRRIGATING 1.0mm TIP, INSULATED, 00841019119891, Comfort Grip, Class IIb, Kirwan Surgical Products LLC, EUDAMED registration

Kirwan Surgical Products LLCClass IIbEU EUDAMEDTrade name: Comfort Grip

VerifiedEUDAMED · official EU database

Device classification

Risk class: Class IIb
CND nomenclatures code: K0201010601
Trade name: Comfort Grip
Implantable: No
Reusable: No
Measuring function: No

Registration information

Primary DI: 00841019119891
Basic UDI: B-00841019119891
Version date: January 22, 2025
Manufacturer last update: June 24, 2021
Active status: Yes

Manufacturer

Manufacturer name: Kirwan Surgical Products LLC
Country: United States
Country type: NON_EU
Address: 180 Enterprise Drive Marshfield
Email: mprario@ksp.com

Authorized representative

Name: MPS Medical Product Service GmbH
SRN: DE-AR-000005009
Country: Germany
Address: 20 Borngasse Braunfels
Email: g.froemel@mps-gmbh.eu
Telephone: +49 6442962073

Regulatory information

Competent authority: DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I
Applicable legislation: MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market: Germany
Market available: Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None

Device characteristics

Human tissues: No
Animal tissues: No

Device description (EMDN)

OPEN ELECTROSURGERY FORCEPS, SINGLE-USE

About this record

Access comprehensive regulatory information for DISPOSABLE BIPOLAR FORCEPS, 7" (17.8cm), COMFORT GRIP NON STICK IRRIGATING 1.0mm TIP, INSULATED in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 00841019119891 and manufactured by Kirwan Surgical Products LLC in United States.

This page provides complete registration details including trade name (Comfort Grip), manufacturer information, authorized representative details, competent authority (DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.