Identity
- Trade Name
- Foryou EUDAMED4L FDA UDI
- Generic Name
- Negative-pressure wound therapy system pump, electric FDA UDI
- Device Name
- Foryou NPWT Pro, Foryou NPWT Stan EUDAMED
- Model / Reference
- NP32 EUDAMEDFDA UDINP32Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970076370014 EUDAMEDFDA UDI
- Basic UDI-DI
- 697007637NP32JJ EUDAMED
- 510(k) Number
- K113236 FDA UDI
- FDA Product Code
- OMP FDA UDI
- EMDN Code
- A0699 DRAINAGE AND FLUID COLLECTION DEVICES - OTHER 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
- Romania 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Foryou by 4L Health Co., Ltd. — Class IIa — 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 | 697007637NP32JJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 169bca6d-7bed-40c4-940f-0e02750f3a2e 61 fields · synced Aug 1, 2026
- FDA UDI 731364b8-bc07-4038-92f5-1016bae9eb6d 33 fields · synced May 30, 2026