KDANS SURGICAL PRIVATE LIMITED
Vật tư và thiết bị nha khoa, Ấn Độ
KDANS SURGICAL PRIVATE LIMITED là công ty trong lĩnh vực Vật tư và thiết bị nha khoa tại GANDHINAGAR Gujarat, Ấn Độ.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- GANDHINAGAR Gujarat, India
- Categories
- Vật tư và thiết bị nha khoa, Vật tư y tế và chăm sóc sức khỏe
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)