FDA Registration
Active
🇹🇷 Türkiye
Helix - Tie X 300 Champagne - 8682549130459
Reg #: 3015990335
·
FEI: 3015990335
·
Expires 2025
Products
1
Proprietary Names
106
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EARTEKNIK ISITME VE ODIOMETRI CIHAZLARI SAN. VE TIC. A.S
- Registration Number
- 3015990335
- FEI Number
- 3015990335
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Karamehmet MH. Avrupa Serbest Bolgesi, Adnan Arisoy Bulvari No 13/305
- City
- Ergene Tekirdag
- Country
- TR
Owner / Operator
- Firm Name
- EARTEKNIK ISITME VE ODIOMETRI CIHAZLARI SAN. vE TIC. A.S
- Operator Number
- 10080092
- Address
- Karamehmet MH. Avrupa Serbest Bolgesi, Adnan Arisoy Bulvari No 13/305
- City
- Ergene
- State
- Tekirdag
- Postal Code
- 59930
- Country
- TR
- Correspondent
- Sait Sakin
US Agent
- Business Name
- Healthcare International Partners Llc
- Contact Name
- Margarita Morales
- Address
- 2750 Sw 145th Ave Ste 101
- City
- Miramar
- State
- FL
- ZIP
- 33027
- Country
- US
- [email protected]
- Phone
- 786 3602695 ext. 104
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2021-01-12 |
Proprietary Names
Helix - Tie X 300 Champagne - 8682549130459
Helix - Tie X 100 Champagne - 8682549130435
Helix - Tie XR 100 Champagne - 8682549131715
Earnet - Biyonix E SPn - 8682549133955
Helix - Alfa W 400 SPn - 8682549130503
Anaton - TIE X 90 Champagne - 8682549137298
Helix - Alfa W 200 SPn - 8682549130480
Earnet - Biyonix P+ SPn - 8682549133986
Anaton - Nida M 70 Gn - 8682549137311
Earnet - Tie X Pr Champagne - 8682549133931
Anaton - Nida M 60 Gn - 8682549137304
Anaton - TIE XR 60 Champagne - 8682549138523
Earnet - Biyonix Pr SPn - 8682549133979
Helix - Tie XR 400 Champagne - 8682549131746
Earnet - TIE X Pr Painted Black - 8682549136840
Earnet - Tie XR Pr Champagne - 8682549135256
Anaton - TIE XR 70 Champagne - 8682549138530
Earnet - Biyonix U SPn - 8682549133962
Earnet - Biyonix U HPn Champagne - 8682549135713
Earnet - Biyonix U SPn Painted Chocolate Brown - 8682549136635
Helix - Alfa W 200 HPn Champagne - 8682549132897
Earnet - TIE X P+ Painted Black - 8682549136833
Earnet - Tie X U Champagne - 8682549133924
Helix - TIE XR 300 Iceberg - 8682549132361
Helix - TIE X 400 Silver - 8682549131777
Earnet - Biyonix U SPn Silver - 8682549134808
Earnet - TIE X P+ Silver - 8682549134433
Earnet - Tie X P Plus Champagne - 8682549133948
Anaton - TIE X 80 Champagne - 8682549137281
Helix - Alfa W 300 HPn Champagne - 8682549132903
Helix - Alfa W 400 SPn Champagne - 8682549132262
Helix - Alfa W 400 SPn Silver - 8682549132309
Anaton - TIE XR 80 Champagne - 8682549138547
Helix - Alfa W 300 SPn - 8682549130497
Anaton - Nida M 60 HGn Champagne - 8682549138127
Helix - Alfa W 300 SPn Champagne - 8682549132255
Earnet - Biyonix Pr SPn Painted Chocolate Brown - 8682549136802
Anaton - Nida M 90 Gn - 8682549137335
Anaton - TIE X 60 Champagne - 8682549137267
Earnet - Tie XR E Champagne - 8682549135232
Anaton - Nida M 80 Gn - 8682549137328
Helix - Tie X 200 Champagne - 8682549130442
Helix - Tie XR 300 Champagne - 8682549131739
Earnet - Tie XR P Plus Champagne - 8682549135249
Anaton - TIE X 70 Champagne - 8682549137274
Earnet - Tie X E Champagne - 8682549133917
Helix - Tie XR 200 Champagne - 8682549131722
Helix - Alfa W 100 SPn - 8682549130473
Helix - Tie X 400 Champagne - 8682549130466
Earnet - TIE X Pr Silver - 8682549134563
Anaton - Nida M 70 HGn Champagne - 8682549138165
Anaton - Nida M 70 Gn Champagne - 8682549139902
Earnet - TIE X E Painted Black - 8682549136826
Anaton - Nida M 90 HGn Champagne - 8682549138240
Earnet - Biyonix Pr HPn Champagne - 8682549135706
Anaton - Nida M 80 Gn Champagne - 8682549139919
Anaton - Nida M 90 Gn Silver - 8682549139964
Anaton - TIE XR 90 Champagne - 8682549138554
Earnet - Tie XR U Champagne - 8682549135263
Anaton - Nida M 60 Gn Champagne - 8682549139896
Earnet - TIE X E Silver - 8682549134570
Earnet - TIE XR U Iceberg - 8682549134860
Anaton - Nida M 60 Gn Silver - 8682549139933
Anaton - TIE X 70 Silver - 8682549139377
Helix - TIE XR 100 Iceberg - 8682549132347
Helix - Alfa W 100 HPn Champagne - 8682549132880
Anaton - TIE XR 80 Iceberg - 8682549137366
Helix - TIE XR 200 Iceberg - 8682549132354
Earnet - Biyonix E SPn Silver - 8682549134792
Earnet - TIE XR P+ Iceberg - 8682549134846
Anaton - TIE X 90 Silver - 8682549139391
Earnet - Biyonix U SPn Black - 8682549134730
Helix - Alfa W 300 SPn Silver - 8682549132293
Anaton - Nida M 80 HGn Champagne - 8682549138202
Earnet - Biyonix P+ HPn Champagne - 8682549135690
Helix - TIE X 200 Silver - 8682549131760
Anaton - TIE XR 70 Iceberg - 8682549137359
Earnet - Biyonix P+ SPn Silver - 8682549134822
Helix - Alfa W 100 SPn Champagne - 8682549132231
Anaton - TIE X 80 Silver - 8682549139384
Helix - Alfa W 200 SPn Champagne - 8682549132248
Earnet - Biyonix Pr SPn Champagne - 8682549134617
Helix - Alfa W 400 HPn Champagne - 8682549132873
Earnet - Biyonix E SPn Champagne - 8682549134594
Earnet - Biyonix E SPn Painted Chocolate Brown - 8682549136628
Anaton - TIE XR 90 Iceberg - 8682549137373
Anaton - Nida M 90 Gn Champagne - 8682549139926
Helix - TIE XR 400 Iceberg - 8682549132378
Earnet - Biyonix U SPn Champagne - 8682549134600
Earnet - TIE X U Painted Black - 8682549136857
Anaton - TIE X 60 Silver - 8682549139360
Anaton - Nida M 80 Gn Silver - 8682549139957
Earnet - Biyonix P+ SPn Champagne - 8682549134624
Anaton - TIE XR 60 Iceberg - 8682549137342
Helix - TIE X 300 Silver - 8682549132224
Helix - TIE X 100 Black - 8682549132316
Earnet - TIE XR Pr Iceberg - 8682549134853
Earnet - TIE X U Silver - 8682549134426
Anaton - Nida M 70 Gn Silver - 8682549139940
Helix - Alfa W 100 SPn Silver - 8682549132279
Earnet - Biyonix E HPn Champagne - 8682549135683
Earnet - Biyonix P+ SPn Painted Chocolate Brown - 8682549136819
Earnet - TIE XR E Iceberg - 8682549134839
Helix - Alfa W 200 SPn Silver - 8682549132286
Helix - TIE X 100 Silver - 8682549132217
Earnet - Biyonix Pr SPn Silver - 8682549134815
Establishment Types
Manufacture Medical Device