FDA Registration
Active
🇫🇮 Finland
MECTALENT LTD.
Reg #: 3013156185
·
FEI: 3013156185
·
Expires 2026
Products
25
Proprietary Names
14
Establishment Types
1
Classifications
25
Registration Details
- Registration Name
- MECTALENT LTD.
- Registration Number
- 3013156185
- FEI Number
- 3013156185
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Veistamotie 15
- City
- Oulu Kainuu
- Country
- FI
Owner / Operator
- Firm Name
- Mectalent Ltd.
- Operator Number
- 10052131
- Address
- Veistamotie 15
- City
- Oulu
- State
- Kainuu
- Postal Code
- FI-90620
- Country
- FI
- Correspondent
- Pirkko H Niemimaki
US Agent
- Business Name
- Conmed Corporation
- Contact Name
- Brent Lalomia
- Address
- 11311 Concept Blvd
- City
- Largo
- State
- FL
- ZIP
- 33773
- Country
- US
- [email protected]
- Phone
- 269 3772187
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2023-11-13 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2016-06-18 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2023-11-13 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2023-11-13 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2023-11-13 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2023-11-13 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2023-11-13 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2023-11-13 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-11-13 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2016-06-18 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2023-11-13 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2026-01-15 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2016-06-18 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2023-11-13 |
| Staple Driver | HXJ | Class 1 | Orthopedic | No | 2023-11-13 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2023-11-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-11-13 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2023-11-13 |
| Template | HWT | Class 1 | Orthopedic | No | 2023-11-13 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2023-11-13 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2023-11-13 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2023-11-13 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2023-11-13 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2023-11-13 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2016-06-18 |
Proprietary Names
Activa:RemeOs
Inion Instrumentation
ARTHROSCOPIC PISTON
APPLICATOR
PERCUTANEOUS TIP
PERCUTANEOUS PISTON
ARTHROSCOPIC TIP
Inion ACL Instrumentation
K-Wire
Activa Instruments; RemeOs Instrument
Handle
Housing
Activa Instrument; RemeOs Instrument
Drill bit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)