FDA Registration
Active
🇩🇪 Germany
IT DR. GAMBERT GMBH
Reg #: 9613449
·
FEI: 3002739067
·
Expires 2026
Products
1
Proprietary Names
98
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IT DR. GAMBERT GMBH
- Registration Number
- 9613449
- FEI Number
- 3002739067
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- HINTER DEM CHOR 21
- City
- WISMAR Mecklenburg-Western Pomerania
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K002384
Owner / Operator
- Firm Name
- IT DR. GAMBERT GMBH
- Operator Number
- 9042424
- Address
- HINTER DEM CHOR 21, --
- City
- WISMAR, M-V
- State
- Mecklenburg-Western Pomerania
- Postal Code
- 23966
- Country
- DE
- Correspondent
- Demian - Gambert
US Agent
- Business Name
- INTERNATIONAL BUSINESS STRATEGIES
- Contact Name
- WILLIAM ROETTGER
- Address
- 2061 Middle Street, #35
- City
- Sullivans Is
- State
- SC
- ZIP
- 29482
- Country
- US
- [email protected]
- Phone
- 843 2240553 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2007-12-18 |
Proprietary Names
M-43GE
M-07T
M-15
M-15T incl. Flow Diverter
MLF-04
MLF-80
M-04
M-43T
M-14T
MLF-42HL
M-16HTT
M-16VT
M-01L2
M-43
M-43T Doppelpack
M-14
M-12 Doppelpack
M-15TL incl. Flow Diverter
MLF-80HL
MLF-03
M-07S
MLF-45H
M-03T
M-08
M-05
M-25T
MLF-16HL
M-04T
M-25 incl. Flow Diverter
M-07ST
M-43GE Dual Pack
M-15M
M-44
M-02L2
M-18T
M-09T
MLF-12A
MLF-44PI
M-15T
M-04CT
MLF-16D
M-12T
M-01TL2
M-16T
M-44PI
M-45
MLF-16DE
M-48
M-14TB
M-25
M-16PT
M-11
M-16HT
M-03T incl. Flow Diverter
M-48 incl. Flow Diverter
M-13
MLF-19
M-03 incl. Flow Diverter
MLF-11
M-02TL2
MLF-16H
M-12 incl. translucent Flow Diverter
M-09M
M-03
M-47
M-01
M-07 incl. Flow Diverter
M-12A
M-12
MLF-19GE
M-80
M-25T incl. Flow Diverter
M-06
MLF-07M
M-04C
M-09F
M-10
M-16
MLF-44
MLF-43
M-43 Doppelpack
M-12A Doppelpack
M-08T
MLF-11K
M-14ST
MLF-15M
MLF-16
MLF-17
M-02T
MLF-16DD
MLF-60HC
M-12 incl.white Diverter
M-02
M-09
M-03HDM incl. Flow Diverter
M-01T
MLF-15
M-15 incl. Flow Diverter
Establishment Types
Manufacture Medical Device