← Back to catalogue
Isolation Gown
EUDAMEDClass I (EU MDR)
Ref 40016Model 40016, 40085, 40021, KIMONO
Identity
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- 40016, 40085, 40021, KIMONO EUDAMED40016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973219625002 EUDAMED
- Basic UDI-DI
- 697321962105JU EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMEDT0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) 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
Isolation Gown by Ammex-Weida (Hubei) Health and Safety 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 | 697321962105JU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000011701
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 222c281b-6a67-4cef-819b-5d62156173d4 61 fields · synced Oct 6, 2026
- EUDAMED b8dcded8-40f1-47dc-86af-9ac32f0d59bb 61 fields · synced Jul 28, 2026