FDA Registration
Active
🇪🇸 Spain
PRIM,S.A.
Reg #: 1000626221
·
FEI: 1000626221
·
Expires 2026
Products
12
Proprietary Names
26
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- PRIM,S.A.
- Registration Number
- 1000626221
- FEI Number
- 1000626221
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Calle Yolanda Gonzalez, No. 15
- City
- Mostoles Madrid (Province)
- Country
- ES
Owner / Operator
- Firm Name
- PRIM,S.A.
- Operator Number
- 9012483
- Address
- POLIGONO INDUSTRIAL NO.1,, CALLE YOLANDA GONZALEZ (Antigua CALLE F.) NO. 15
- City
- MOSTOLES
- State
- Madrid (Province)
- Postal Code
- 28938
- Country
- ES
US Agent
- Business Name
- Business Excellence Consulting, Inc.
- Contact Name
- Solmarie Velez Rivera
- Address
- #48 City View Plaza Suite 802, Road 165 km 1.2
- City
- Guaynabo
- State
- PR
- ZIP
- 00968
- Country
- US
- [email protected]
- Phone
- 787 7057272
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2019-02-08 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2023-04-17 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2006-01-26 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 1995-02-21 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2023-04-17 |
| Orthosis, Truncal, Pregnancy | QSB | Class 1 | Physical Medicine | No | 2022-06-11 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 1998-11-20 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2019-02-08 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 1998-11-20 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2023-04-17 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 1998-12-01 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2006-01-26 |
Proprietary Names
AQTIVO, Joint, Tight, External Brace
AIRTEX
MOTTIO, Joint, Elbow, External Brace
AQTIVO, Joint, Elbow, External Brace
PRIM
CLUBAX AJUSTABLE
ESSENTIAL
HUMERUX
AIRMED
CLUBAX MOVIL
MYPRIM KIDS
HEMISAFE
AQTIVO, Joint, Wrist, External Brace
SPINAIR
CONFORT
Camp
PRIMSPINE
PRIMSPINE MAMMY
AQTIVO
MYPRIMKIDS
MOTTIO
PRIMSPINE CARE +
CAMP XXI
PRIMSPINE CARE
BEBAX
CAMP
Establishment Types
Manufacture Medical Device