KDANS SURGICAL PRIVATE LIMITED
牙科用品和设备, 印度
KDANS SURGICAL PRIVATE LIMITED 是一家牙科用品和设备公司，总部位于印度古吉拉特邦甘地那加尔。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- GANDHINAGAR Gujarat, India
- Categories
- 牙科用品和设备, 医疗保健用品
Listed in a source registry
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- export-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- fda-registered (green), checked 2026-09-02 FDA
- fda-contract-manufacturer (green), checked 2026-09-02 FDA
- debarment-clear (green), checked 2026-09-02 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- sanctions-clear (green), checked 2026-09-02 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)