← Back to catalogue
Foryou
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NP70AModel NP70Ref FB10MModel DK10Ref DK10SSRef NP70ERef DK10LDRef NP50Ref CA32Model CA32, CA50Ref FB10SRef FS10LModel DK10SS,DK10MS,DK10LS,DK10XS,DK10AS,DK10SD,DK10MD,DK10LD,DK10XD,DK10AD
Identity
- Trade Name
- Foryou EUDAMED4L FDA UDI
- Generic Name
- Negative-pressure wound therapy system dressing set FDA UDI
- Device Name
- PU NPWT Dressing Kit EUDAMEDForyou NPWT Pump EUDAMEDSuction Canister EUDAMEDNPWT Dressing Kit EUDAMED
- Model / Reference
- NP70 EUDAMEDNP70A EUDAMEDDK10 EUDAMEDFB10M EUDAMEDDK10SS EUDAMEDFDA UDINP70E EUDAMEDDK10LD EUDAMEDNP50 EUDAMEDCA32, CA50 EUDAMEDCA32 EUDAMEDFB10S EUDAMEDFS10L EUDAMEDDK10SS,DK10MS,DK10LS,DK10XS,DK10AS,DK10SD,DK10MD,DK10LD,DK10XD,DK10AD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970076370748 EUDAMED06970076370144 EUDAMED06970076370076 EUDAMEDFDA UDI06970076370731 EUDAMED06970076370083 EUDAMED06970076370021 EUDAMED06970076370038 EUDAMED06970076370151 EUDAMED06970076370182 EUDAMED
- Basic UDI-DI
- 697007637NP70JS EUDAMED697007637DK10F9 EUDAMED697007637NP50JL EUDAMED697007637CA32DS EUDAMEDB-06970076370076 EUDAMED
- 510(k) Number
- K190119 FDA UDI
- FDA Product Code
- OMP FDA UDI
- EMDN Code
- A0699 DRAINAGE AND FLUID COLLECTION DEVICES - OTHER EUDAMEDM040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
- GMDN Term
- Negative-pressure wound therapy system dressing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Greece EUDAMEDRomania EUDAMEDSlovakia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDEUDAMEDFDA 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Foryou by 4L Health Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697007637NP70JS | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697007637NP70JS | 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
- 4L Health Co., Ltd
- EUDAMED SRN
- CN-MF-000017929
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (11)
- EUDAMED 200e5ed4-6003-44e9-80e8-91d015610998 61 fields · synced Sep 18, 2026
- EUDAMED 4fd6d412-6399-4adc-9353-0d9c7801f448 61 fields · synced May 16, 2026
- EUDAMED 96b1b7c6-1ce9-47ad-a295-29d7956cd758 61 fields · synced May 17, 2026
- EUDAMED 868de0e2-e7ff-4baf-86b3-4446399394ef 61 fields · synced May 17, 2026
- EUDAMED 90ffdb20-c269-4de2-88d1-9a8e5ec22580 61 fields · synced May 17, 2026
- EUDAMED b60bee09-6b34-4155-a84a-3bf89661754c 61 fields · synced May 18, 2026
- EUDAMED abfe6fdf-b72a-452f-81b6-55db85fdabec 61 fields · synced May 18, 2026
- EUDAMED a7c42332-0a2f-4175-8ddd-9e6c8ea52084 61 fields · synced May 18, 2026
- EUDAMED 65dfdb7f-a496-42ba-9130-6cb10d0dd580 61 fields · synced May 18, 2026
- FDA UDI 8997433f-7b3b-429d-bf91-fee712cfd1f3 33 fields · synced May 30, 2026
- EUDAMED 5f5e6b79-75f4-4793-a7c7-ebfc62d0da35 61 fields · synced Jul 19, 2026