FDA Registration
Active
🇫🇷 France
OTP-EPID
Reg #: 3009607881
·
FEI: 3009607881
·
Expires 2025
Products
1
Proprietary Names
27
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- QUALIFORMED SAS
- Registration Number
- 3009607881
- FEI Number
- 3009607881
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 19 impasse de La Boetie
- City
- La Roche Sur Yon Pays de la Loire
- Country
- FR
Owner / Operator
- Firm Name
- QualiFormeD SAS
- Operator Number
- 10040700
- Address
- 19 impasse de La Boetie
- City
- La Roche Sur Yon
- State
- Pays de la Loire
- Postal Code
- 85000
- Country
- FR
- Correspondent
- Stephane Beaumont
US Agent
- Business Name
- Speed To Market, Inc.
- Contact Name
- Maren Kroenke
- Address
- 10 Evergreen Way
- City
- Nederland
- State
- CO
- ZIP
- 80466
- Country
- US
- [email protected]
- Phone
- 303 9564233
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Phantom, Anthropomorphic, Radiographic | IXG | Class 1 | Radiology | No | 2012-05-09 |
Proprietary Names
OTP-EPID
OTP-TOMOT-SR
OTP-CROSS-KV2-EL
OTP-ABACUS-CL
OTP-CROSS-KV2-VA
OTP-BALL
OTP-ALIGN
OTP-ABACUS-EL
OTP-ISO+
OTP-DISTO
OTP-PLATE-VA
OTP-CROSS
OTP-PLAN
OTP-FIELD
OTP-CROSS-MV
OTP-FIELD28
OTP-PLATE-EL
OTP-LAS
OTP-FIELD-STICKER
OTP-EPID-L
OTP-TOMOT-ST
OTP-FIELD03
OTP-FIELD08
OTP-FIELD18
MAGICTAPE
OTP-FIELD01
FIELD-TAPE
Establishment Types
Manufacture Medical Device