Identity
- Trade Name
- Air Compression Therapy System EUDAMED
- Device Name
- mattress EUDAMEDalternating pressure mattress with pump EUDAMED
- Model / Reference
- MB300 EUDAMEDSY200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 6971066420719 EUDAMED6971066420702 EUDAMED
- Basic UDI-DI
- 697106642MB3009X EUDAMED697106642SY200GV EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
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
Air Compression Therapy System by Foshan Hongfeng Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697106642MB3009X | Class I | Active |
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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 (2)
- EUDAMED b6b64164-17a7-4c21-877b-6aea50d8075a 61 fields · synced Jul 30, 2026
- EUDAMED 1f46e725-4207-4899-85ca-0a1fa9f7ba78 61 fields · synced Jul 30, 2026