Identity
- Device Name
- Disposable Medical Coveralls EUDAMED
- Model / Reference
- E-3PJ EUDAMEDE-4PJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974633370004 EUDAMED06974633370011 EUDAMED
- Basic UDI-DI
- 697463337E-3PJD7 EUDAMED697463337E-4PJDC EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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 Medical Coveralls by Sichuan Shuzhan New Materials 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 | 697463337E-3PJD7 | Class I | Active |
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Manufacturer
- Manufacturer
- Sichuan Shuzhan New Materials Co., Ltd
- EUDAMED SRN
- CN-MF-000010104
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 19a31c86-740d-4f3c-9649-e3d977e9bed5 61 fields · synced Aug 2, 2026
- EUDAMED 25e447c6-9223-41a0-aae9-2230681b4bd7 61 fields · synced May 18, 2026