FDA Registration
Active
🇨🇭 Switzerland
MAWATEC AG
Reg #: 3010158639
·
FEI: 3010158639
·
Expires 2026
Products
7
Proprietary Names
157
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- MAWATEC AG
- Registration Number
- 3010158639
- FEI Number
- 3010158639
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Selzacherstrasse 32
- City
- Selzach Solothurn
- Country
- CH
Owner / Operator
- Firm Name
- Mawatec AG
- Operator Number
- 10043561
- Address
- Selzacherstrasse 32
- City
- Selzach
- State
- Solothurn
- Postal Code
- 2545
- Country
- CH
- Correspondent
- Dominik Lehmann
US Agent
- Business Name
- EMERGO GLOBAL REPRESENTATION LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Caves Rd Ste 1 Ste 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2015-01-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2015-01-16 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2013-02-27 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2013-02-27 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-02-27 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2023-08-14 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-27 |
Proprietary Names
MONOAXIAL T-15 TORX SCREWDRIVER
DJD II BODY
NUMELOCK II HUMERUS PLATEDISTAL LAT. 5 HOLE RIGHT
NUMELOCK II RADIUS PLATE DISTAL 4 HOLE LEFT
NUMELOCK II RADIUS PLATE DISTAL 4 HOLE RIGHT
NUMELOCK II HUMERUS PLATEPROXIMAL 4 HOLE RIGHT
NUMELOCK II HUMERUS PLATEDISTAL LAT. 3 HOLE RIGHT
NUMELOCK II HUMERUS PLATEDISTAL LAT. 2 HOLE LEFT
NUMELOCK II HUMERUS PLATEPROXIMAL 4 HOLE LEFT
NUMELOCK II HUMERUS PLATEDISTAL MED. 3 HOLE
NUMELOCK II HUMERUS PLATEPROXIMAL 6 HOLE RIGHT
NUMELOCK II HUMERUS PLATEDISTAL MED. 1 HOLE
NUMELOCK II HUMERUS PLATEDISTAL LAT. 5 HOLE LEFT
NUMELOCK II HUMERUS PLATEPROXIMAL 8 HOLE LEFT
NUMELOCK II HUMERUS PLATEPROXIMAL 10 HOLE RIGHT
NUMELOCK II HUMERUS PLATEDISTAL LAT. 2 HOLE RIGHT
NUMELOCK II HUMERUS PLATEPROXIMAL 6 HOLE LEFT
NUMELOCK II HUMERUS PLATEPROXIMAL 10 HOLE LEFT
NUMELOCK II RADIUS PLATE DISTAL 3 HOLE RIGHT
NUMELOCK II HUMERUS PLATEPROXIMAL 8 HOLE RIGHT
NUMELOCK II RADIUS PLATE DISTAL 3 HOLE LEFT
NUMELOCK II HUMERUS PLATEDISTAL LAT. 3 HOLE LEFT
NUMELOCK II SYSTEM
OMEGA3 TSP PLATE
VARIAX CLAVICLE - TRIAL - SUP LATERAL / 3 HOLE / LEFT
VARIAX CLAVICLE - TRIAL - SUP DECREASED / 7 HOLE / RIGHT
VARIAX CLAVICLE - TRIAL- ANT LATERAL / 8 HOLE
VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 8 HOLE
VARIAX CLAVICLE - TRIAL - SUP LATERAL / 3 HOLE / RIGHT
VARIAX CLAVICLE - TRIAL - SUP LATERAL / 4 HOLE / LEFT
VARIAX CLAVICLE - TRIAL - SUP DECREASED / 6 HOLE / LEFT
VARIAX CLAVICLE - TRIAL - SUP INCREASED / 8 HOLE / RIGHT
VARIAX CLAVICLE - TRIAL - SUP LATERAL / 7 HOLE / RIGHT
VARIAX CLAVICLE - TRIAL - SUP DECREASED / 10 HOLE / LEFT
VARIAX CLAVICLE - TRIAL - SUP DECREASED / 8 HOLE / LEFT
VARIAX CLAVICLE - TRIAL- ANT LATERAL / 6 HOLE
VARIAX CLAVICLE - TRIAL - SUP INCREASED / 8 HOLE / LEFT
VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 7 HOLE
VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 6 HOLE
VARIAX CLAVICLE - TRIAL - SUP DECREASED / 8 HOLE / RIGHT
VARIAX CLAVICLE - TRIAL - SUP DECREASED / 6 HOLE / RIGHT
VARIAX CLAVICLE - TRIAL- ANT LATERAL / 7 HOLE
VARIAX CLAVICLE - TRIAL - SUP LATERAL / 4 HOLE / RIGHT
VARIAX CLAVICLE - TRIAL - SUP LATERAL / 7 HOLE / LEFT
VARIAX CLAVICLE - TRIAL - SUP INCREASED / 10 HOLE / RIGHT
VARIAX CLAVICLE - TRIAL - SUP DECREASED / 7 HOLE / LEFT
VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 10 HOLE
VARIAX CLAVICLE - TRIAL - SUP INCREASED / 10 HOLE / LEFT
VARIAX CLAVICLE - TRIAL - SUP LATERAL / 5 HOLE / LEFT
VARIAX CLAVICLE - TRIAL - SUP DECREASED / 10 HOLE / RIGHT
VARIAX CLAVICLE - TRIAL - SUP LATERAL / 5 HOLE / RIGHT
Aiming Device 3.5mm
4 SCREW HOLDING SLEEVE
DRILL GUIDE BLOCK COMPACT 4 HOLE
OVERDRILL GUIDE
LOCKING SCREW HOLDING SLEEVE
NUMELOCK II HUMERUS PLATE DISTAL MED. 5 HOLE
K WIRE SLEEVE FOR 5 SYSTEM
DRILL SLEEVE L=68MM
DRILL GUIDE BLOCK HII 10 HOLE
DEPTH GAUGE FOR LOCKING SCREWS
LOCKING INSERT INTRODUCER
5 SCREW HOLDING SLEEVE
DRILL GUIDE FOR CIRCULAR LOCKING HOLES
PERCUTANEOUS DRILL SLEEVE
DRILL SLEEVE HANDLE
VARIAX DRILL GUIDE 2MM COMPRESSION AND POLYAXIAL
SCREWDRIVER BLADE, AO, T10
MONOAXIAL T-20 TORX SCREWDRIVER
K WIRE SLEEVE L=60MM
DRILL GUIDE FOR OBLONG COMPRESSION HOLES
DRILL SLEEVE SHORT 3.2mm COMP.
VARIAX DRILL GUIDE 2.6MM COMPRESSION AND POLYAXIAL
NEUTRAL PERCUTANEOUS DRILL SLEEVE - DIA 2.5
DRILL SLEEVE SHORT 2.5mm NEUT.
DRILL SLEEVE SHORT 2.5mm BUTTR
DRILL SLEEVE SHORT 2.5mm COMP.
DRILL SLEEVE FOR 4 SYSTEM
DRILL GUIDE BLOCK HII 5 HOLE
K WIRE SLEEVE FOR 4 SYSTEM
T-20 SCREWDRIVER BIT
DRILL SLEEVE SHORT 3.2mm BUTTR
DRILL SLEEVE FOR 5 SYSTEM
T-15 SCREWDRIVER BIT
OMEGA KEYLESS PLATE 145
OMEGA KEYLESS PLATE 135
OMEGA KEYLESS PLATE 130
OMEGA KEYLESS PLATE 140
OMEGA KEYLESS PLATE 150
HOOK PLATE 9 HOLE / 20MM / LEFT
HOOK PLATE 7 HOLE / 12MM / RIGHT
HOOK PLATE 5 HOLE / 16MM / RIGHT
HOOK PLATE 9 HOLE / 16MM / LEFT
HOOK PLATE 7 HOLE / 20MM / RIGHT
PLATE TRIAL FOR HOOK PLATE DEPTH - 20MM LEFT
HOOK PLATE 6 HOLE / 16MM / LEFT
HOOK PLATE 6 HOLE / 20MM / LEFT
HOOK PLATE 5 HOLE / 12MM / RIGHT
HOOK PLATE 5 HOLE / 12MM / LEFT
HOOK PLATE 5 HOLE / 16MM / LEFT
PLATE TRIAL FOR HOOK PLATE DEPTH - 12MM RIGHT
PLATE TRIAL FOR HOOK PLATE DEPTH - 20MM RIGHT
PLATE TRIAL FOR HOOK PLATE DEPTH - 16MM RIGHT
HOOK PLATE 9 HOLE / 12MM / RIGHT
HOOK PLATE 5 HOLE / 20MM / RIGHT
HOOK PLATE 9 HOLE / 16MM / RIGHT
HOOK PLATE 6 HOLE / 12MM / RIGHT
HOOK PLATE 6 HOLE / 20MM / RIGHT
HOOK PLATE 7 HOLE / 16MM / RIGHT
HOOK PLATE 7 HOLE / 12MM / LEFT
HOOK PLATE 6 HOLE / 16MM / RIGHT
HOOK PLATE 7 HOLE / 16MM / LEFT
PLATE TRIAL FOR HOOK PLATE -RULER
HOOK PLATE 5 HOLE / 20MM / LEFT
HOOK PLATE 9 HOLE / 12MM / LEFT
PLATE TRIAL FOR HOOK PLATE DEPTH - 16MM LEFT
HOOK PLATE 7 HOLE / 20MM / LEFT
PLATE TRIAL FOR HOOK PLATE DEPTH - 12MM LEFT
HOOK PLATE 9 HOLE / 20MM / RIGHT
HOOK PLATE 6 HOLE / 12MM / LEFT
OMEGA PLUS SIDEPLATE 130X4 SLOT
OMEGA PLUS SUPRA PLATE 98X10 SLOT KEYED
OMEGA PLUS SIDEPLATE 135X2 SLOT
OMEGA PLUS SIDEPLATE 130X5 SLOT
OMEGA PLUS SIDEPLATE 135X5 SLOT
OMEGA PLUS SIDEPLATE 140X3 SLOT
OMEGA PLUS SIDEPLATE 150X3 SLOT
OMEGA PLUS SIDEPLATE 140X4 SLOT
OMEGA PLUS SIDEPLATE 140X2 SLOT
OMEGA PLUS SIDEPLATE 130X2 SLOT
OMEGA PLUS SUPRA PLATE 98X14 SLOT KEYED
OMEGA PLUS SB SIDEPLATE 135X4 SLOT
OMEGA PLUS SUPRA PLATE 98X8 SLOT KEYED
OMEGA PLUS SIDEPLATE 135X3 SLOT
OMEGA PLUS SIDEPLATE 135X4 SLOT
OMEGA PLUS SUPRA PLATE 98X6 SLOT KEYED
OMEGA PLUS SIDEPLATE 130X3 SLOT
OMEGA PLUS SIDEPLATE 145X4 SLOT
OMEGA PLUS SIDEPLATE 130X6 SLOT
OMEGA PLUS SB SIDEPLATE 135X5 SLOT
OMEGA PLUS SIDEPLATE 145X3 SLOT
OMEGA PLUS SIDEPLATE 150X4 SLOT
OMEGA PLUS SIDEPLATE 140X5 SLOT
OMEGA PLUS SUPRA PLATE 98X12 SLOT KEYED
OMEGA PLUS SIDEPLATE 135X6 SLOT
SUPRAPECTINEAL PLATE QLS RIGHT
INFRAPECTINEAL PLATE SMALL QLS RIGHT
SUPRAPECTINEAL PLATE QLS LEFT
INFRAPECTINEAL PLATE SMALL QLS LEFT
INFRAPECTINEAL PLATE LARGE QLS RIGHT
INFRAPECTINEAL PLATE LARGE QLS LEFT
ANTERIOR MIDSHAFT PLATE - 7 HOLE
ANTERIOR MIDSHAFT PLATE - 8 HOLE
ANTERIOR LATERAL PLATE - 6 HOLE
ANTERIOR LATERAL PLATE - 8 HOLE
ANTERIOR LATERAL PLATE - 7 HOLE
ANTERIOR MIDSHAFT PLATE - 10 HOLE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)