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Manual Medical Beds
EUDAMEDFDA UDIClass I (EU MDR)
Ref APE-15Model APE-15、APE-14、APE-13、AA-6、FS-01
Identity
- Trade Name
- Maisilide FDA UDI
- Generic Name
- Manual hospital bed FDA UDI
- Device Name
- Manual Medical Beds EUDAMED
- Model / Reference
- APE-15、APE-14、APE-13、AA-6、FS-01 EUDAMEDAPE-15 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976696813207 EUDAMED06976696813405 FDA UDI
- Basic UDI-DI
- 697669681MMB001UZ EUDAMED
- Direct Marketing DI
- 06976696813207 EUDAMED
- FDA Product Code
- FNJ FDA UDI
- EMDN Code
- V080602 MANUAL MEDICAL BEDS EUDAMED
- GMDN Term
- Manual hospital bed FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5120 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Manual Medical Beds by Shandong Deman Medical Equipment Group 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 | 697669681MMB001UZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shandong Deman Medical Equipment Group Co., LTD
- EUDAMED SRN
- CN-MF-000037481
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED d8f9492d-74a2-461c-a23b-45b08df4349d 61 fields · synced Jun 18, 2026
- FDA UDI 083da73c-55d2-46d5-bbf2-fe04f6c46963 32 fields · synced May 30, 2026