FDA Registration Active 🇩🇪 Germany

PAT CBL 5WIRE 2x5 RA SNAPS BI-POLAR GRAY

Reg #: 3004035727 · FEI: 3004035727 · Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1

Registration Details

Registration Name
BERND RICHTER GMBH
Registration Number
3004035727
FEI Number
3004035727
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Hansestrasse 4
City
Wipperfuerth North Rhine-Westphalia
Country
DE

Regulatory Submissions

510(k) Number
K152626

Owner / Operator

Firm Name
Bernd Richter GmbH
Operator Number
10046701
Address
Hansestrasse 4
City
Wipperfuerth
State
North Rhine-Westphalia
Postal Code
51688
Country
DE
Correspondent
Christopher Kott

US Agent

Business Name
Bernd Richter USA, Inc.
Contact Name
David Krohn
Address
2097 Iglehart Ave.
City
Saint Paul
State
MN
ZIP
55104
Country
US
Phone
651 4420278

Products

Device Name Product Code
Electrocardiograph, Ambulatory (Without Analysis) MWJ

Proprietary Names

PAT CBL 5WIRE 2x5 RA SNAPS BI-POLAR GRAY PAT CBL H3+ 5WIRE AHA SNAP PAT CBL H3+ 5WIRE/2CH SNAP PAT CBL H3+ 5-WIRE 2X5 RA SNAPS IEC GRAY CABLE H3+ USB DOWNLOAD GRAY PAT CBL H3+ 5WIRE IEC SNAP PATIENT CABLE H3+ 5-WIRE AHA SNAP GRAY PATIENT CABLE H3+ 5-WIRE IEC SNAP GRAY PAT CBL H3+ 5WIRE SHORT AHA SNAP PATIENT CABLE H3+ 5-WIRE 2-CH SNAP GRAY PAT CBL H3+ 5-WIRE 2X5 RA SNAPS AHA GRAY

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)