Identity
- Trade Name
- PE GOWN EUDAMED
- Device Name
- PE GOWN EUDAMED
- Model / Reference
- M, L, XL, XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972979890392 EUDAMED
- Basic UDI-DI
- 697297989355Y EUDAMED
- Direct Marketing DI
- 06972979890392 EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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 Gown by Shandong Aishule Hygiene 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 | 697297989355Y | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Aishule Hygiene Products Co., Ltd
- EUDAMED SRN
- CN-MF-000032582
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 5b8aa62b-ed00-4b96-8533-b7708b580b66 61 fields · synced Jul 15, 2026
- EUDAMED 5b8aa62b-ed00-4b96-8533-b7708b580b66-1 61 fields · synced Jun 10, 2026