Identity
- Trade Name
- PRESTIGE EUDAMED
- Device Name
- Medical Face Mask EUDAMED
- Model / Reference
- M1100 EUDAMED110110 EUDAMED110620 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974960060135 EUDAMED06974960066205 EUDAMED
- Basic UDI-DI
- 697496006M1100D5 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Norway 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
Prestige by Xiantao S&J Protective 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 | 697496006M1100D5 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao S&J Protective Products Co., Ltd
- EUDAMED SRN
- CN-MF-000009006
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 61d2a036-2393-435d-bc5e-bb21a069f577 61 fields · synced Jul 9, 2026
- EUDAMED 45840545-23f1-498b-8c05-bf7ce3a29ff7 61 fields · synced May 17, 2026