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Endostall
EUDAMEDFDA UDIClass I (EU MDR)
Ref HF6002-17P+HF601Ref HF6002-17P+HF601 Model HF6002
Identity
- Trade Name
- ENDOSTALL EUDAMEDFOFO FDA UDI
- Generic Name
- Alternating-pressure bed mattress system FDA UDI
- Device Name
- Medical air mattress with pump EUDAMED
- Model / Reference
- HF6002-17P+HF601 EUDAMEDFDA UDIHF6002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 6971066421983 EUDAMED06971066421914 EUDAMED6971066422041 EUDAMED06971066423741 FDA UDI
- Basic UDI-DI
- 69710664260000W4 EUDAMED697106642HF600263 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 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
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
Endostall 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 (4)
- EUDAMED b4cca17e-5007-44ae-92ba-c9c06616512d 61 fields · synced Jul 23, 2026
- EUDAMED 72fdfaa1-1628-4696-8ba1-993800641050 61 fields · synced May 19, 2026
- EUDAMED b489b71b-6ae0-4a4b-ac04-1f93a53ab75b 61 fields · synced May 19, 2026
- FDA UDI 49155af6-af42-44aa-aa21-acd40576cc01 32 fields · synced May 30, 2026