FDA Registration
Active
🇩🇪 Germany
RAUMEDIC - Muenchberg
Reg #: 3006946348
·
FEI: 3006946348
·
Expires 2026
Products
8
Proprietary Names
12
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- RAUMEDIC - Muenchberg
- Registration Number
- 3006946348
- FEI Number
- 3006946348
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Hermann-Staudinger Strasse 2
- City
- Helmbrechts Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K130529
Owner / Operator
- Firm Name
- RAUMEDIC
- Operator Number
- 10024509
- Address
- Hermann-Staudinger-Str. 2
- City
- Helmbrechts
- State
- Bavaria
- Postal Code
- 95233
- Country
- DE
- Correspondent
- Hannes Engelhardt
US Agent
- Business Name
- RAUMEDIC Inc.
- Contact Name
- Jeremy Smith
- Address
- 235 Broadpointe Dr
- City
- Mills River
- State
- NC
- ZIP
- 28759
- Country
- US
- [email protected]
- Phone
- 828 4903262
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2012-10-17 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2012-10-17 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2013-11-13 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2015-04-21 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2026-04-01 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2021-08-19 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2025-02-07 |
| Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation | QQK | Class 3 | Unknown | No | 2022-04-27 |
Proprietary Names
RAUMEDIC-PTO-Monitoring-System
RAUMEDIC® -ICP-TEMP-Monitoring-System
KIRO Set
MAJ-1607/1608
MPR2 logO DATALOGGER
RAUMEDIC® -ICP-Monitoring-System ventricular
BOLT KIT CH9
DRILL KIT CH9
Spliceable Tunneling Sleeve CH8
RAUMEDIC-ICP-Monitoring-System
RAUMEDIC® NEUROMONITORING-SYSTEM
OrganOx Metra System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device