FDA Registration
Active
🇩🇪 Germany
SARSTEDT AG & CO. KG
Reg #: 9617475
·
FEI: 3002808075
·
Expires 2026
Products
23
Proprietary Names
11
Establishment Types
2
Classifications
23
Registration Details
- Registration Name
- SARSTEDT AG & CO. KG
- Registration Number
- 9617475
- FEI Number
- 3002808075
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Sarstedtstrasse 1
- City
- NUMBRECHT North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- BK040080
Owner / Operator
- Firm Name
- SARSTEDT AG & CO. KG
- Operator Number
- 8010078
- Address
- SARSTEDTSTR. 1, --
- City
- NUMBRECHT
- State
- North Rhine-Westphalia
- Postal Code
- 51588
- Country
- DE
- Correspondent
- JOCHEN - HOFFMANN
US Agent
- Business Name
- SARSTEDT, INC.
- Contact Name
- Susan Smith
- Address
- 1025 Saint James Church Rd
- City
- Newton
- State
- NC
- ZIP
- 28658
- Country
- US
- [email protected]
- Phone
- 828 4654000
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 1996-03-18 |
| Device, Warming. Blood And Plasma | KZL | Class 2 | Hematology | No | 2007-12-07 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2007-12-07 |
| Tube, Sedimentation Rate | GHC | Class 1 | Hematology | No | 1997-10-20 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2007-12-07 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2007-12-07 |
| Blood/Plasma Collection Device For Dna Testing | PJE | Class 2 | Clinical Chemistry | No | 2007-12-07 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2000-02-18 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2001-07-09 |
| Tube, Collection, Capillary Blood | GIO | Class 1 | Hematology | No | 1977-11-18 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2016-08-25 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 1996-04-01 |
| Device, Heat-Sealing | KSD | Class 1 | Hematology | No | 2000-02-04 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 1996-03-18 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 1998-11-25 |
| Test, Erythrocyte Sedimentation Rate | JPH | Class 1 | Hematology | No | 1997-10-20 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2008-06-19 |
| Dish, Tissue Culture | KIZ | Class 1 | Hematology | No | 2007-12-11 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 1998-11-25 |
| Flask, Tissue Culture | KJA | Class 1 | Hematology | No | 2007-12-11 |
| Device, Automated Sedimentation Rate | GKB | Class 1 | Hematology | No | 1996-05-02 |
| Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | NNL | Class 1 | Pathology | No | 2016-08-25 |
| Mixer, Blood Tube | GLE | Class 1 | Clinical Chemistry | No | 1977-11-18 |
Proprietary Names
SAHARA-TSC 115V
Tourniquet
Urine container, Urin-Monovettes, Salivettes, tubes, Screw caps for container, Feaces container, Inserts
General Centrifuges LC
Urine Container, Urine Monovettes, Faeces Container, Tubes, Screw caps, CryoPure
Monovettes, Monovette Needles, Multifly Needles, Adapters
Monovettes, Monovette Needles, Micro needles, Multifly Needles, Adapters
Cool Transport Container
S-Monovette ACD-A
SAHARA-III basic model 115V
SAHARA-III MAXITHERM 115V
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device