Identity
- Trade Name
- Alternating Pressure Mattress EUDAMEDYHMED FDA UDI
- Generic Name
- Alternating-pressure bed mattress FDA UDI
- Device Name
- Alternation Pressure Mattresses EUDAMED
- Model / Reference
- QDC-303 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944749500305 EUDAMEDFDA UDI
- Basic UDI-DI
- 694474950030LF EUDAMED
- FDA Product Code
- FNM FDA UDI
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
- GMDN Term
- Alternating-pressure bed mattress FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5550 FDA UDI
- Market of Registration
- Italy 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Alternating Pressure Mattress by Guangdong Yuehua Medical Instrument Factory Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 694474950030LF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000004539
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED a9a4634b-3cbc-4985-abac-397a4cfcfdda 61 fields · synced Jun 18, 2026
- FDA UDI 64fbcb4f-53c8-4997-8835-7bd85ff56a60 32 fields · synced May 30, 2026