FDA Registration Active 🇩🇪 Germany

PATIENT CBL, STRESS, PRO, PUSH, IEC

Reg #: 3004035727 · FEI: 3004035727 · Expires 2025
Products
1
Proprietary Names
10
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
K082478

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
Spirometer, Diagnostic BZG

Proprietary Names

PATIENT CBL, STRESS, PRO, PUSH, IEC PATIENT CBL,STRESS, PRO,CLIP,IEC PATNT CBL, LONG, REST, PRO, BAN, IEC PATIENT CBL, REST, PRO, BANANA, IEC PATIENT CBL,REST, PRO,BANANA,AHA PATNT CBL, STRESS,LG LIMB, PRO, CLIP, AHA PATIENT CBL, STRESS, PRO, CLIP, AHA PATNT CBL,STRESS,LG LIMB, PRO,CLIP,IEC PATNT CBL,STRESS,LG LIMB, PRO,PUSH,IEC PATIENT CABLE, MD, BANANA, AHA

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)