FDA Registration
Active
🇩🇪 Germany
SYCOTEC GMBH & CO KG
Reg #: 3009302876
·
FEI: 3009302876
·
Expires 2026
Products
3
Proprietary Names
20
Establishment Types
3
Classifications
3
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Registration Details
- Registration Name
- SYCOTEC GMBH & CO KG
- Registration Number
- 3009302876
- FEI Number
- 3009302876
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Wangener Strasse 78
- City
- Leutkirch Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K090937
Owner / Operator
- Firm Name
- SYCOTEC GMBH & CO KG
- Operator Number
- 10047093
- Address
- Wangener Strasse 78
- City
- Leutkirch
- State
- Baden-Wurttemberg
- Postal Code
- 88299
- Country
- DE
- Correspondent
- Ralph Hoffmann
US Agent
- Business Name
- OzGlobal LLC
- Contact Name
- Eric Ozelski
- Address
- 2631 Fountain Hills Drive
- City
- Wexford
- State
- PA
- ZIP
- 15090
- Country
- US
- [email protected]
- Phone
- 412 4209985
Products
Proprietary Names
E-SANAO Advantage
E-STATIS Advantage
A-dec XC10 Electric Motor
Midwest E Electric Handpiece System
E-SANAO Prep
Star ETorque Electric Motor System
E-STATIS Prep
NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
STATMATIC 31
Midwest Plus Automate Spray
Midwest® 6-pin Coupler, K-style CE
STATIS, ML and SL
SANAO 10L/10
SANAO 40ST
ETorque Handpieces
SANAO 200L
SANAO 40L/40
SANAO PSI/PSO
Midwest E Attachments
STERLING
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility