Identity
- Trade Name
- 0.20 Micron Filter EUDAMED.20 Micron Filter FDA UDI
- Generic Name
- Syringe filter, clinical FDA UDI
- Device Name
- 0.20 Micron Filter EUDAMEDFilters out particles and microbiological contamination 0.22 micron and larger. FDA UDI
- Model / Reference
- 9301 EUDAMEDFDA UDI
- Description
- Filters out particles and microbiological contamination 0.22 micron and larger. FDA UDI
Identifiers
- Catalog Number
- 9301 FDA UDI
- Primary DI / UDI-DI
- 00813465012125 EUDAMEDFDA UDI
- Basic UDI-DI
- 081346501HM11SWL EUDAMED
- FDA Product Code
- JRL FDA UDI
- EMDN Code
- A04010101 WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS) EUDAMED
- GMDN Term
- Syringe filter, clinical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Malta 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Syringe filter, clinical
.20 Micron Filter by Hurricane Medical — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Syringe filter, clinical.
- Spectrum, Inc. — Spectrum Co. · Class II
- Advanced Instruments RBC Reagent Filtration Kit — Advanced Instruments, LLC · Class II
- Epimed — EPIMED INTERNATIONAL, INC. · Class II
- Spectrum, Inc. — Spectrum Co. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hurricane Medical
Sources (2)
- FDA UDI db5174a1-bf21-4e42-a280-edc4be887b82 34 fields · synced Jul 29, 2026
- EUDAMED 6f4918d4-fc8d-4d50-b603-7babb8904754 61 fields · synced Jul 29, 2026