Electric Hospital Bed
by Bio Tech Health medical Supplies(Tianjin) Co., Ltd 46 variants
Ref BT-HE04Model 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 06977883420031 | 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- Withdrawn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, BT-HE04
- Primary DI / UDI-DI
- 06977883420031
- Basic UDI-DI
- 697788342BTKYL001RQ
- EMDN Code
- V08060101 Hospital/home care electric medical beds
- Device Class
- Class I
- EU market of registration
- Estonia
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