Identity
- Trade Name
- Syringe Unit 35ml EUDAMEDEquashield FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- EQUASHIELD® CSTD EUDAMED
- Model / Reference
- SU-35/2 EUDAMEDEquashield Syringe Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290013484062 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001348401A4 EUDAMED
- FDA Product Code
- ONB FDA UDI
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
- GMDN Term
- Medication transfer set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Syringe Unit 35ml by Equashield Medical Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729001348401A4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Equashield Medical Ltd.
- EUDAMED SRN
- IL-MF-000012194
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 96e3f5a8-ba97-40bf-aa9c-ad86dc0beaaf 61 fields · synced Jul 16, 2026
- FDA UDI b373e119-c5ce-4be6-bbaa-f62993eb8fd2 32 fields · synced May 30, 2026