FDA Registration
Active
🇮🇪 Ireland
ArcRoyal uc
Reg #: 3011144486
·
FEI: 3011144486
·
Expires 2026
Products
6
Proprietary Names
13
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- ArcRoyal uc
- Registration Number
- 3011144486
- FEI Number
- 3011144486
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Virginia Road
- City
- Kells Meath
- Country
- IE
Owner / Operator
- Firm Name
- O & M Halyard, Inc.
- Operator Number
- 10039033
- Address
- 1220 Old Alpharetta Rd. Ste 320
- City
- Alpharetta
- State
- GA
- Postal Code
- 30005
- Country
- US
- Correspondent
- Angela L Bunn
US Agent
- Business Name
- O&M HALYARD, INC.
- Contact Name
- Angela Bunn
- Address
- 1220 Old Alpharetta Rd. Ste 320
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
- [email protected]
- Phone
- 770 4011697
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2016-03-17 |
| Obstetrical Kit | OKV | Class 2 | Obstetrics/Gynecology | No | 2015-08-20 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2015-08-14 |
| Cardiac Catheterization Kit | OES | Class 2 | Cardiovascular | No | 2016-06-22 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2015-08-14 |
| Neurological Tray | OJG | Class 1 | Neurology | No | 2015-08-20 |
Proprietary Names
Cardiovascular Procedure Kit
Obstetrical Kit
Eye Kit
Cardiac Catheterization Kit
General Surgery Tray (Kit)
SurgiTrack
Hip Pack
Hand Pack
Knee Pack
Toe Nail Kit
General Convenience Kit
General Purpose Kit
Neurological Tray
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)