Identity
- Trade Name
- Foryou EUDAMED4L FDA UDI
- Generic Name
- Negative-pressure wound therapy system dressing set FDA UDI
- Device Name
- PU NPWT Dressing Kit EUDAMED
- Model / Reference
- DK10 EUDAMEDDK10LS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970076370052 EUDAMEDFDA UDI
- Basic UDI-DI
- 697007637DK10F9 EUDAMED
- 510(k) Number
- K190119 FDA UDI
- FDA Product Code
- OMP FDA UDI
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
- GMDN Term
- Negative-pressure wound therapy system dressing set FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Foryou by 4L Health Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697007637DK10F9 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- 4L Health Co., Ltd
- EUDAMED SRN
- CN-MF-000017929
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED d627685b-7187-45de-99e9-16a7db1c484b 61 fields · synced Jul 10, 2026
- FDA UDI f36dae7b-adf6-4b4a-9633-93ef19daf4c1 33 fields · synced May 29, 2026