Isolation gown
by Xiantao Zhongtai Protective Products Co., Ltd 25 variants
Ref M, 10033, FCHTMModel S,M,L,XL,XXL,XXXL,XXXXL,5XL, Sterilization
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 | Number697443606C000169 | Date12 May 2023 | 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- Withdrawn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
- Trade Name
- Surgical gown
- Device Name
- Isolation gown
- Model / Reference
- S, M, L, XL, XXL, XXXL, XXXXL, 5XL, 10033, Sterilization, FCHTM
- Primary DI / UDI-DI
- 16974436061335, 06974436061031, 16974436061045, 16974436061038
- Basic UDI-DI
- 697443606C000169, 697443606I00018B
- EMDN Code
- T0299, T020401
- Device Class
- Class I
- EU market of registration
- PolandCzechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000008476
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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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