Identity
- Device Name
- PE/CPE Gown EUDAMED
- Model / Reference
- 40045, 40087 EUDAMED40045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973219623008 EUDAMED
- Basic UDI-DI
- 697321962103JQ 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
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
PE/CPE 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 | 697321962103JQ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000011701
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b8db3131-3c40-44c9-9673-dfbb2f035c99 61 fields · synced Jun 18, 2026