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Sign in to claim this brandADVANCE DX, INC.
United States·US-MF-000044758
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 11250, N 118th Way, Scottsdale, United States
- Website
- adx100.com
- —
- —
- [email protected]
- Phone
- +1 949-433-3058
- PRRC Contact
- Mark Pankow
- EUDAMED SRN
- US-MF-000044758
- FDA FEI Number
- 3006457763
- DUNS Number
- 041235184
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Blood Specimen Return Bag | F02 | FDA UDI | Class I | Active |
| Advance Dx Blood Collection Card | CMT01.1 | EUDAMED | Class A | Active |
| Advance Dx Blood Collection Card | WTSSNG100 | EUDAMED | Class A | Active |
| Advance Dx Blood Collection Card | CMT01-MEGA | EUDAMED | Class A | Active |
| "Advance Dx Blood Collection Card | CMT01 | EUDAMEDFDA UDI | Class A | Active |
| Advance Dx Blood Collection Card | CMT01-DBL200SQ | EUDAMED | Class A | Active |
Related Companies
Authorised Representatives
- Obelis s.a. BE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 6, 2021 | Z-2237-2021 | — | terminated | Due to high glucose test results when using the blood collection cards. |