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Heat-Sealing Sterilization Flat reel
EUDAMEDClass I (EU MDR)
Ref HR01K01Model HR01K01, HR02K01
Identity
- Device Name
- Heat-Sealing Sterilization Flat reel EUDAMED
- Model / Reference
- HR01K01, HR02K01 EUDAMEDHR01K01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976800672195 EUDAMED
- Basic UDI-DI
- 697680067Flatreel32 EUDAMED
- EMDN Code
- S01020101 FLAT STERILISATION REELS, 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
Heat-Sealing Sterilization Flat reel 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 | 697680067Flatreel32 | 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 7589cc88-ef70-4808-9665-fd86c87a5b27 61 fields · synced Jul 11, 2026