← Back to catalogue
Gardian™ 25 mm syringe filters, sterile
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6094184Model HP1002
Identity
- Trade Name
- Gardian™ 25 mm syringe filters, sterile EUDAMEDGardian 25 mm Syringe Filter FDA UDI
- Generic Name
- Syringe filter, clinical FDA UDI
- Device Name
- Pall PharmAssure 25mm Syringe Filter with Low Protein Binding Supor Membrane EUDAMED25mm syringe filter with 5.0 micron low protein binding Versapor® membrane FDA UDI
- Model / Reference
- HP1002 EUDAMED6094184 EUDAMEDFDA UDI
- Description
- 25mm syringe filter with 5.0 micron low protein binding Versapor® membrane FDA UDI
Identifiers
- Catalog Number
- 6094184 FDA UDI
- Primary DI / UDI-DI
- 05034480315472 EUDAMEDFDA UDI
- Basic UDI-DI
- 5034480SRGF05NINVNL EUDAMED
- FDA Product Code
- FPB FDA UDI
- EMDN Code
- A0499 SOLUTION FILTERS - OTHER EUDAMED
- GMDN Term
- Syringe filter, clinical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Belgium 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
No
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
Dimensions & Sizes
- Size
- Pore Size — 5 Micrometer FDA UDI
Gardian™ 25 mm syringe filters, sterile by Pall International SARL — Class IIa — 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 | 5034480SRGF05NINVNL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pall International SARL
- EUDAMED SRN
- CH-MF-000023177
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED e35a9b6a-b3bb-4a7c-b5cc-390fccced7b0 61 fields · synced Jul 8, 2026
- FDA UDI 2bbe40db-ad16-4077-bdbc-f1fc368ed1b9 36 fields · synced May 30, 2026