Electric Hospital Bed
by Bio Tech Health medical Supplies(Tianjin) Co., Ltd 46 variants
Ref HE01Model HE01 HE02 HE03 HE04 HE05 HE06 HE07 HE08 HE09 HE10 HE11 HE12 HE13 HE14 HE15 HE16 BT-A1 BT-A2 BT-A3 BT-A4 BT-A5 BT-A6 BT-A7 BT-A8 BT-A9 BT-A10 BT-A11 BT-A12 BT-A13 BT-A14 BT-A15 BT-A16 BT-A17 BT-A18 BT-A19 BT-A20 BT-A21 BT-A22 BT-A23 BT-A24 BT-A25 etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697788342BTKYL001RQ 06977883420000 | Date10 Oct 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Electric Hospital Bed
- Model / Reference
- HE01 HE02 HE03 HE04 HE05 HE06 HE07 HE08 HE09 HE10 HE11 HE12 HE13 HE14 HE15 HE16 BT-A1 BT-A2 BT-A3 BT-A4 BT-A5 BT-A6 BT-A7 BT-A8 BT-A9 BT-A10 BT-A11 BT-A12 BT-A13 BT-A14 BT-A15 BT-A16 BT-A17 BT-A18 BT-A19 BT-A20 BT-A21 BT-A22 BT-A23 BT-A24 BT-A25 etc, HE01
- Primary DI / UDI-DI
- 06977883420000
- Basic UDI-DI
- 697788342BTKYL001RQ
- EMDN Code
- V08060101 Hospital/home care electric medical beds
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000044246
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No