Identity
- Device Name
- diaper EUDAMED
- Model / Reference
- NB, S, M, L, XL, XXL, XXXL, XXXXL EUDAMEDNB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976849693601 EUDAMED
- Basic UDI-DI
- 697684969D001Q3 EUDAMED
- EMDN Code
- T04010103 INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM 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
diaper by Shandong Guyue Healthcare Appliance 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 | 697684969D001Q3 | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Guyue Healthcare Appliance Co., Ltd
- EUDAMED SRN
- CN-MF-000009844
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 36f37770-37f0-41fe-93af-528f7f84948e 61 fields · synced Jun 20, 2026