Isolation gown
by Shandong Hengfa Hygienic Products Co., Ltd China EUDAMED
Ref LModel L、XL、XXL
EMDN T0299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69470527Isolationgown5B | Date30 Sep 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Isolation gown
- Model / Reference
- L、XL、XXL, L
- Primary DI / UDI-DI
- 06947052700196
- Basic UDI-DI
- 69470527Isolationgown5B
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000027679
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED a748b24c-003a-474a-a4d6-f7285febd8af