← Back to catalogue
Genadyne XLR8+ Negative PRessure Wound Therapy System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A4-S0003
Identity
- Trade Name
- Genadyne XLR8+ Wound Vacuum System FDA UDI
- Generic Name
- Negative-pressure wound therapy system pump, electric FDA UDI
- Device Name
- Genadyne XLR8+ Negative PRessure Wound Therapy System EUDAMEDThe Genadyne XLR8+ is a type of negative pressure wound therapy where its intended use is for patients who would benefit from a suction device particularly as the device may promote wound healing. FDA UDI
- Model / Reference
- A4-S0003 EUDAMEDFDA UDI
- Description
- The Genadyne XLR8+ is a type of negative pressure wound therapy where its intended use is for patients who would benefit from a suction device particularly as the device may promote wound healing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849405011309 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849405011309 EUDAMED
- 510(k) Number
- K143726 FDA UDI
- FDA Product Code
- OMP FDA UDI
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
- GMDN Term
- Negative-pressure wound therapy system pump, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Genadyne XLR8+ Negative PRessure Wound Therapy System by Genadyne Biotechnologies Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00849405011309 | 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
- Genadyne Biotechnologies, Inc.
- EUDAMED SRN
- US-MF-000017992
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED d07019fe-7e5f-49ab-8944-e7d56e9d991b 61 fields · synced Jul 31, 2026
- FDA UDI 03427544-0cc5-43dc-86c7-dbd5693ccdd0 34 fields · synced May 30, 2026