Isolation gowns for medical use
by Shandong Ruyue Medical Technology Co., Ltd. EUDAMED
Active
Ref A-type coat type-160cm×140cmModel A-type coat type-160cm×140cm, A-type coat type-160cm×130cm, A-type coat type-150cm×130cm, A-type coat type-140cm×130cm, A-type coat type-130cm×130cm, A-type coat type-135cm×120cm, A-type coat type-120cm×120cm, etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697357642IG001GF | Date1 Aug 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Isolation gowns for medical use
- Model / Reference
- A-type coat type-160cm×140cm, A-type coat type-160cm×130cm, A-type coat type-150cm×130cm, A-type coat type-140cm×130cm, A-type coat type-130cm×130cm, A-type coat type-135cm×120cm, A-type coat type-120cm×120cm, etc
- Primary DI / UDI-DI
- 06973576423402
- Basic UDI-DI
- 697357642IG001GF
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000041139
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shandong Ruyue Medical Technology Co., Ltd
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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