Identity
- Trade Name
- Spike Adaptor 1J EUDAMED
- Device Name
- EQUASHIELD® CSTD EUDAMED
- Model / Reference
- SA-1J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290013484437 EUDAMED
- Basic UDI-DI
- 729001348401A4 EUDAMED
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spike Adaptor 1J by Equashield Medical Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729001348401A4 | Class I | Active |
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Manufacturer
- Manufacturer
- Equashield Medical Ltd.
- EUDAMED SRN
- IL-MF-000012194
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED dcd12fd3-48c2-4702-9b83-588a6a338d03 61 fields · synced Jul 16, 2026