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Apollo EZ
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 9784M42113Ref 9784K55813Ref 9784NB2213Ref 9784J90213Ref 9784KB0313Ref 9784NA0013Ref 9784J90013Ref 9784KB5313Ref 9784K42813Ref 9784K52313Ref 9784M42013Ref 9784N40013Ref 9784H20013Ref 9784J92213
Identity
- Trade Name
- Apollo EZ EUDAMEDApollo EZ DRF EUDAMEDApollo EUDAMED
- Device Name
- Apollo EUDAMED
- Model / Reference
- 9784M42113 EUDAMED9784K55813 EUDAMED9784NB2213 EUDAMED9784J90213 EUDAMED9784KB0313 EUDAMED9784NA0013 EUDAMED9784J90013 EUDAMED9784KB5313 EUDAMED9784K42813 EUDAMED9784K52313 EUDAMED9784M42013 EUDAMED9784N40013 EUDAMED9784H20013 EUDAMED9784J92213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057737120244 EUDAMED08057737120398 EUDAMED08057737120435 EUDAMED08057737120053 EUDAMED08057737120367 EUDAMED08057737120282 EUDAMED08057737120046 EUDAMED08057737120336 EUDAMED08057737120374 EUDAMED08057737120381 EUDAMED08057737120237 EUDAMED08057737120275 EUDAMED08057737120022 EUDAMED08057737120060 EUDAMED
- Basic UDI-DI
- 805773712FT2209C EUDAMED
- Direct Marketing DI
- 08057737120244 EUDAMED08057737120398 EUDAMED08057737120435 EUDAMED08057737120053 EUDAMED08057737120367 EUDAMED08057737120282 EUDAMED08057737120046 EUDAMED08057737120336 EUDAMED08057737120374 EUDAMED08057737120381 EUDAMED08057737120237 EUDAMED08057737120275 EUDAMED08057737120022 EUDAMED08057737120060 EUDAMED
- EMDN Code
- Z11030701 CONVENTIONAL REMOTE CONTROL TABLES EUDAMEDZ11030702 DIGITAL REMOTE CONTROL TABLES 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
Apollo EZ by Villa Sistemi Medicali S.p.a. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050190 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 805773712FT2209C | Class IIb | Active |
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Manufacturer
- Manufacturer
- Villa Sistemi Medicali S.p.A.
- EUDAMED SRN
- IT-MF-000016860
Sources (15)
- EUDAMED fd579227-f61c-4383-800b-c700c689029e 61 fields · synced Aug 2, 2026
- EUDAMED 3bb7c1cb-10db-4778-870a-b424e973e401 61 fields · synced May 16, 2026
- EUDAMED a79755a6-cc5d-487b-9784-6792a4bb8cd4 61 fields · synced May 16, 2026
- EUDAMED b6b20995-7673-4a01-aadd-671ae5f6f7a0 61 fields · synced May 17, 2026
- EUDAMED fe57c7d7-b65f-420d-bde5-c0fe4758defe 61 fields · synced May 17, 2026
- EUDAMED 997fbc48-cf6f-4a53-a432-686371ebe51d 61 fields · synced May 17, 2026
- EUDAMED 91e2df71-a7cf-431c-b8bc-e6bafc968b15 61 fields · synced May 17, 2026
- EUDAMED b3a7d0f1-dc66-41d8-972c-710d09e01459 61 fields · synced May 17, 2026
- EUDAMED 69c94276-3098-43d2-8423-6454a82146cf 61 fields · synced May 18, 2026
- EUDAMED a2a0ac51-c2ef-444b-b351-0320431afa2d 61 fields · synced May 18, 2026
- EUDAMED e3dc0262-a8e7-4102-9df1-f941e7b18364 61 fields · synced May 18, 2026
- EUDAMED 017a0230-d66c-4ab3-ab10-b67bf133db56 61 fields · synced May 18, 2026
- EUDAMED c65dfabb-9e77-4086-9cc0-4c1656e68545 61 fields · synced May 19, 2026
- EUDAMED 11f71ba0-bc0e-4d91-b96b-d6dd3534a574 61 fields · synced May 19, 2026
- FDA 510(k) K050190 1 fields · synced May 18, 2026