FDA Registration
Active
🇸🇪 Sweden
Wellspect Healthcare
Reg #: 3009632672
·
FEI: 3009632672
·
Expires 2026
Products
12
Proprietary Names
3
Establishment Types
3
Classifications
12
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Registration Details
- Registration Name
- Wellspect Healthcare
- Registration Number
- 3009632672
- FEI Number
- 3009632672
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Aminogatan 1
- City
- Molndal Vastra Gotaland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K113424
Owner / Operator
- Firm Name
- DENTSPLY SIRONA INC
- Operator Number
- 2511302
- Address
- 221 WEST PHILADELPHIA ST., SUITE 60W
- City
- York
- State
- PA
- Postal Code
- 17401
- Country
- US
US Agent
- Business Name
- DENTSPLY SIRONA INC
- Contact Name
- Dan Eagar
- Address
- 13320 Ballantyne Corp Pl
- City
- Charlotte
- State
- NC
- ZIP
- 28277
- Country
- US
- [email protected]
- Phone
- 704 4926977
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2017-04-19 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2012-12-12 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2019-12-06 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2011-12-16 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2001-10-23 |
| Sound, Urethral, Metal Or Plastic | FBX | Class 1 | Gastroenterology, Urology | No | 2011-12-16 |
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2023-12-14 |
| Catheter, Coude | EZC | Class 2 | Gastroenterology, Urology | No | 2023-05-08 |
| Hearing Aid, Bone Conduction, Implanted | MAH | Class 2 | Ear, Nose, Throat | No | 2023-12-14 |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | Class 1 | Gastroenterology, Urology | No | 2025-11-20 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2019-12-06 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2019-12-06 |
Proprietary Names
Implant
catheter
PrimeTaper
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device