FDA Registration
Active
🇫🇷 France
ASKORN MEDICAL
Reg #: 3008880500
·
FEI: 3008880500
·
Expires 2026
Products
4
Proprietary Names
12
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ASKORN MEDICAL
- Registration Number
- 3008880500
- FEI Number
- 3008880500
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 44c rue de Bray
- City
- Cesson Sevigne Bretagne
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K243477
Owner / Operator
- Firm Name
- Askorn Medical
- Operator Number
- 10044425
- Address
- 44c rue de Bray
- City
- Cesson Sevigne
- State
- Bretagne
- Postal Code
- F-35510
- Country
- FR
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Tendon, Passive | HXA | Class 2 | Orthopedic | No | 2025-04-02 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2018-02-12 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-06-10 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2024-04-10 |
Proprietary Names
Universal Tendon Spacer
Knee Positioning Device
OSSKAR
Chirobloc Ring
Chirobloc 3
Chirobloc Wrist
Chirobloc Ballast
Chirobloc Large
Chirobloc Small
Oxford Concise MCL Retractor
Cannulated Compressor PFCC
BE POD MEDIO/AR PIED POIGNEE DROITE MINI AO
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device