FDA Registration
Active
🇬🇧 United Kingdom
ALTOMED LTD.
Reg #: 9614107
·
FEI: 3002867000
·
Expires 2026
Products
21
Proprietary Names
4
Establishment Types
2
Classifications
21
Registration Details
- Registration Name
- ALTOMED LTD.
- Registration Number
- 9614107
- FEI Number
- 3002867000
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14 Burford Way
- City
- Boldon Colliery South Tyneside
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K170591
Owner / Operator
- Firm Name
- ALTOMED LTD.
- Operator Number
- 9043181
- Address
- 14 Burford Way, BOLDON BUSINESS, PARK,
- City
- BOLDON, TYNE & WEAR
- State
- GB-NOTA
- Postal Code
- NE35 9PZ
- Country
- GB
US Agent
- Business Name
- Microsurgical Technology
- Contact Name
- Sylvia Lemke
- Address
- 8415 154th Ave Ne
- City
- Redmond
- State
- WA
- ZIP
- 98052
- Country
- US
- [email protected]
- Phone
- 888 2793323
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Probe | HXB | Class 1 | Orthopedic | No | 2000-10-03 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 2018-06-22 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2000-10-03 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2018-06-22 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2000-10-03 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2000-10-03 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2000-10-03 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2000-10-03 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2000-10-03 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2000-10-03 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2000-10-03 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2000-10-03 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2000-10-03 |
| Weights, Eyelid, External | MML | Class 2 | Ophthalmic | No | 2017-10-31 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2000-10-03 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2000-10-03 |
| Clip, Lens, Trial, Ophthalmic | HPB | Class 1 | Ophthalmic | No | 2000-10-03 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2000-10-03 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2000-10-03 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2000-10-03 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2000-10-03 |
Proprietary Names
Altomed
Malhotra Endonasal DCR Nibbler Delicate
Traquair Periosteal Elevator
Altomed Malhotra Platinum Segments
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility