Identity
- Trade Name
- FOFO EUDAMED
- Device Name
- Suction machine EUDAMEDAir compression therapy system EUDAMED
- Model / Reference
- 0003 EUDAMED0004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 96971066420002 EUDAMED
- Basic UDI-DI
- 69710664291000XC EUDAMED69710664230000V3 EUDAMED
- EMDN Code
- A0601010201 DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER EUDAMEDZ120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Fofo by Foshan Hongfeng Co., Ltd. — Class IIa — 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 | 69710664291000XC | Class IIa | 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 fe839adc-e822-4772-adec-b5e4bf24d2d8 61 fields · synced Jul 30, 2026
- EUDAMED 9a74d127-cc55-455a-8e07-41974242e74f 61 fields · synced May 17, 2026