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Disposable isolation gown
EUDAMEDClass I (EU MDR)
Ref #8201DModel #8201B, #8201D, #8201E
Identity
- Device Name
- Disposable isolation gown EUDAMED
- Model / Reference
- #8201B, #8201D, #8201E EUDAMED#8201D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977405670074 EUDAMED
- Basic UDI-DI
- 697740567DIG01K2 EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER 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
Yes
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
Disposable isolation gown by Guangdong Deshang Medical Products 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 | 697740567DIG01K2 | Class I | Active |
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Manufacturer
- Manufacturer
- Guangdong Deshang Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000041574
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f74b5ad3-db87-4d27-88ad-6f6823aeeefc 61 fields · synced Jun 19, 2026