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Sterilization Pouch
EUDAMEDClass I (EU MDR)
Ref SP01K01Model SP01K01, SP02K01, SP03K01
Identity
- Device Name
- Sterilization Pouch EUDAMED
- Model / Reference
- SP01K01, SP02K01, SP03K01 EUDAMEDSP01K01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976800672249 EUDAMED
- Basic UDI-DI
- 697680067PouchBU EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM 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
Sterilization Pouch 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 | 697680067PouchBU | 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 d670f14c-8469-430f-9c7f-93c8d682c40b 61 fields · synced Jun 18, 2026