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Caps
EUDAMEDClass I (EU MDR)
Ref SH12A01,Model SH12A01, SH12A02, SH12B01, SH12B02, SH12C01, SH12D01, SH12E01
Identity
- Device Name
- Caps EUDAMED
- Model / Reference
- SH12A01, SH12A02, SH12B01, SH12B02, SH12C01, SH12D01, SH12E01 EUDAMEDSH12A01, EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976800670269 EUDAMED
- Basic UDI-DI
- 697680067CapsXW EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) 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
Caps 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 | 697680067CapsXW | 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 93c6caa2-a28c-4ebb-89d5-7b58cd2274ad 61 fields · synced Jun 18, 2026