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Primax International Cyberbloc Fp-S
EUDAMEDClass IIb (EU MDR)
Ref 95 01 000 / 95 03 000 / 95 06 000 / 95 08 000Model CYBERBLOC FP-SRef 95 01 000; 95 03 000; 95 06 000; 95 08 000Model ARCO FP-S
Identity
- Trade Name
- PRIMAX INTERNATIONAL CYBERBLOC FP-S EUDAMEDCyberbloc FP-S EUDAMED
- Device Name
- CYBERBLOC FP-S EUDAMED
- Model / Reference
- CYBERBLOC FP-S EUDAMED95 01 000 / 95 03 000 / 95 06 000 / 95 08 000 EUDAMEDARCO FP-S EUDAMED95 01 000; 95 03 000; 95 06 000; 95 08 000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670570 EUDAMED
- Basic UDI-DI
- B-08055186670570 EUDAMED805518667FP-SFH EUDAMED
- Direct Marketing DI
- 08055186670570 EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Primax International Cyberbloc Fp-S by A.T.S. Applicazione Tecnologie Speciali s.r.l. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08055186670570 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08055186670570 | Class IIb | Active |
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Manufacturer
- Manufacturer
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- EUDAMED SRN
- IT-MF-000010734
Sources (3)
- EUDAMED bdabbd48-4b93-490c-ab38-056a1a1d2137 61 fields · synced Oct 7, 2026
- EUDAMED 1cb44d97-e6e1-4652-baf5-b207dafaf198 61 fields · synced May 18, 2026
- EUDAMED 1cb44d97-e6e1-4652-baf5-b207dafaf198-1 61 fields · synced Jun 10, 2026