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Sheets
EUDAMEDClass I (EU MDR)
Ref MY11G01Model MY11G01, MY11G02, MY16J01, MY16Q01
Identity
- Device Name
- Sheets EUDAMED
- Model / Reference
- MY11G01, MY11G02, MY16J01, MY16Q01 EUDAMEDMY11G01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976800670788 EUDAMED
- Basic UDI-DI
- 697680067SheetsN2 EUDAMED
- EMDN Code
- T030502 BED AND STRETCHER HYGIENIC COVERS 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
Sheets by Sinopharm Fortune International Trading Corp. — 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 | 697680067SheetsN2 | Class I | Active |
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Manufacturer
- Manufacturer
- Sinopharm Fortune International Trading Corp.
- EUDAMED SRN
- CN-MF-000038309
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e7ca5843-d6af-458e-bb53-77a6b8098750 61 fields · synced Jul 24, 2026