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Bactisure Wound Lavage
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SL-0002510(k) K192349
Identity
- Trade Name
- Bactisure Wound Lavage EUDAMEDBactisure™ FDA UDI
- Generic Name
- Antimicrobial wound irrigation solution FDA UDI
- Device Name
- Bactisure Wound Lavage EUDAMED
- Model / Reference
- SL-0002 EUDAMED00-8887-002-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864076000292 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00864076000292 EUDAMED
- 510(k) Number
- K161165 FDA UDI
- FDA Product Code
- FQH FDA UDI
- EMDN Code
- V0999 FLUIDS/GASES FOR CLINICAL/THERAPEUTICAL USE - OTHER EUDAMED
- GMDN Term
- Antimicrobial wound irrigation solution FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
- Total Volume — 1000 Milliliter FDA UDI
Bactisure Wound Lavage by Next Science LLC — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192349 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00864076000292 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Next Science LLC
- EUDAMED SRN
- US-MF-000030681
- FDA Applicant
- Next Science, LLC
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 2100339b-efdb-4b68-9ecc-147ebdc3be75 85 fields · synced Jun 19, 2026
- FDA UDI eb21c387-7490-45ce-a836-c248a22ce568 36 fields · synced May 27, 2026
- FDA 510(k) K192349 1 fields · synced May 18, 2026