Identity
- Trade Name
- FOFO EUDAMEDFDA UDI
- Generic Name
- Alternating-pressure bed mattress system FDA UDI
- Device Name
- Medical air mattress with pump EUDAMEDBubble Medical Air Mattress EUDAMED
- Model / Reference
- HF6001+HF62012 EUDAMEDFDA UDIHF6001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971066421761 EUDAMED06971066420009 EUDAMEDFDA UDI
- Basic UDI-DI
- 69710664260000W4 EUDAMED697106642HF60015Z EUDAMED
- Direct Marketing DI
- 06971066420009 EUDAMED
- FDA Product Code
- FNM FDA UDI
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
- GMDN Term
- Alternating-pressure bed mattress system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5550 FDA UDI
- Market of Registration
- Germany EUDAMEDItaly 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 UDIEUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fofo by Foshan Hongfeng Co., Ltd. — Class I — 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 | 69710664260000W4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Foshan Hongfeng Co. Ltd.
- EUDAMED SRN
- CN-MF-000016042
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 943070b9-116d-4eab-9063-e1556748c547 61 fields · synced Jul 28, 2026
- EUDAMED 75ad4d32-7df6-4993-94b9-07c68030eb46 61 fields · synced May 18, 2026
- FDA UDI f287bf3e-bc19-4481-b2fc-bc67313b574b 32 fields · synced May 30, 2026