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Isovac
EUDAMEDClass IIa (EU MDR)
Ref EIV0108-GRCModel Isovac, 3-Pack, GRCRef EIV0107-GRCModel Isovac, Single, GRCRef EIV0108-POLModel Isovac, 3-Pack, POLRef EIV0107-BENModel Isovac, Single, BEN
by Zyris, Inc.
Identity
- Trade Name
- Isovac EUDAMED
- Model / Reference
- Isovac, 3-Pack, GRC EUDAMEDEIV0108-GRC EUDAMEDIsovac, Single, GRC EUDAMEDEIV0107-GRC EUDAMEDIsovac, 3-Pack, POL EUDAMEDEIV0108-POL EUDAMEDIsovac, Single, BEN EUDAMEDEIV0107-BEN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810032661519 EUDAMED00810032661410 EUDAMED00810032661533 EUDAMED00810032661380 EUDAMED
- Basic UDI-DI
- B-00810032661519 EUDAMEDB-00810032661410 EUDAMEDB-00810032661533 EUDAMEDB-00810032661380 EUDAMED
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMEDPoland EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Isovac by Zyris, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00810032661519 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zyris, Inc.
- EUDAMED SRN
- US-MF-000034843
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED c70cc76f-e6dd-4eea-bcf3-928cb076ca60 61 fields · synced Aug 4, 2026
- EUDAMED 1ff54671-5c80-441b-a977-602d6c80536a 61 fields · synced May 18, 2026
- EUDAMED 09b54d6f-047b-4c6a-a7ba-20105f30c4f7 61 fields · synced May 19, 2026
- EUDAMED 6418ab68-0980-4a9a-b86b-816c687a9fc2 61 fields · synced May 19, 2026