Identity
- Trade Name
- Mininurse FDA UDI
- Generic Name
- Manual hospital bed FDA UDI
- Device Name
- Manual bed EUDAMED
- Model / Reference
- A1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06948286700181 EUDAMEDFDA UDI
- Basic UDI-DI
- 69482867ManualBed0001HL 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Manual bed by Hebei Pukang Medical Instruments 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 | 69482867ManualBed0001HL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hebei Pukang Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000008800
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 48b45975-8202-4e08-8a0d-0ac4ffa8b7a7 61 fields · synced Oct 5, 2026
- FDA UDI ad2fbb89-1f6d-45c3-b6e4-e5dcb2b00851 32 fields · synced May 29, 2026