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Treatment Bed
EUDAMEDClass I (EU MDR)
Ref SKY-IModel SKY-I, SKY-II, SKY-III, SKY-IV,etc
Identity
- Device Name
- Treatment Bed EUDAMED
- Model / Reference
- SKY-I, SKY-II, SKY-III, SKY-IV,etc EUDAMEDSKY-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974539962959 EUDAMED
- Basic UDI-DI
- 697453996TreatmentBedQC EUDAMED
- EMDN Code
- V080603 TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Treatment Bed by Jiangsu Saikang Medical Equipment Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697453996TreatmentBedQC | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Saikang Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000002228
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 896a4e04-5d63-4979-ad26-b4b0ab804d3b 61 fields · synced Oct 7, 2026