Identity
- Trade Name
- SURGISTAR FDA UDI
- Generic Name
- Surgical fluid/gas irrigator FDA UDI
- Model / Reference
- Fluid Filter EUDAMED501030 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00878799008077 EUDAMEDFDA UDI
- Basic UDI-DI
- 087879900FLUIDFILTERPT EUDAMED
- FDA Product Code
- BSN FDA UDI
- EMDN Code
- A0499 SOLUTION FILTERS - OTHER EUDAMED
- GMDN Term
- Surgical fluid/gas irrigator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5130 FDA UDI
- Market of Registration
- Northern Ireland 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
No
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
501030 by Surgistar Inc. — 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 | 087879900FLUIDFILTERPT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Surgistar Inc.
- EUDAMED SRN
- US-MF-000003747
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED ca12f0c5-1d92-4b40-81a9-6240331776d1 61 fields · synced Jun 18, 2026
- FDA UDI c9fd229e-1fb6-478b-b844-c7bb1706756c 33 fields · synced May 30, 2026