FDA Registration
Active
🇦🇹 Austria
BIEGLER GMBH
Reg #: 3005813632
·
FEI: 3005813632
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- BIEGLER GMBH
- Registration Number
- 3005813632
- FEI Number
- 3005813632
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ALLHANGSTRASSE 18A
- City
- MAUERBACH Niederosterreich
- Country
- AT
Regulatory Submissions
- 510(k) Number
- K121198
Owner / Operator
- Firm Name
- BIEGLER GMBH
- Operator Number
- 9069662
- Address
- ALLHANGSTRASSE 18A, --
- City
- MAUERBACH
- State
- Niederosterreich
- Postal Code
- 3001
- Country
- AT
- Correspondent
- INGEBORG - BIEGLER
US Agent
- Business Name
- ProMedic, LLC
- Contact Name
- Matt Dryden
- Address
- 131 Bay Point Dr. NE
- City
- St Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2013-11-13 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2012-12-13 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2015-04-28 |
| Block, Heating | JRG | Class 1 | Clinical Chemistry | No | 2013-11-13 |
Proprietary Names
Duplocath
BW 685S
BW 685
EasySpray
autopress
Fibrinotherm
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device