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Gardian™ 25 mm syringe filters, sterile
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6764192Model 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 0.2 micron low protein binding Supor® membrane FDA UDI
- Model / Reference
- HP1002 EUDAMED6764192 EUDAMEDFDA UDI
- Description
- 25mm syringe filter with 0.2 micron low protein binding Supor® membrane FDA UDI
Identifiers
- Catalog Number
- 6764192 FDA UDI
- Primary DI / UDI-DI
- 05034480315465 EUDAMEDFDA UDI
- Basic UDI-DI
- 5034480SRGF05NINVNL EUDAMED
- FDA Product Code
- FMF 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
- 880.5860 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 — 0.2 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 |
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Manufacturer
- Manufacturer
- Pall International SARL
- EUDAMED SRN
- CH-MF-000023177
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 95cc95b2-dce9-4244-a74d-1e14bda5faaf 61 fields · synced Jul 23, 2026
- FDA UDI 64edd4ef-e371-4133-920f-df0c1b8a5e4e 36 fields · synced May 30, 2026