Identity
- Trade Name
- Sterilization Reel EUDAMED
- Device Name
- Self-Sealing Sterilization Pouch & Sterilization Reel EUDAMED
- Model / Reference
- HD-R200200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974321449142 EUDAMED
- Basic UDI-DI
- 697432144SP001F9 EUDAMED
- EMDN Code
- S01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 Reel by Jiujiang HuaDa Medical Dressing Co., Ltd. — Class I — CE/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 | 697432144SP001F9 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiujiang HuaDa Medical Dressing Co., Ltd.
- EUDAMED SRN
- CN-MF-000024512
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED e9b7338e-1bac-462c-a8c0-eea9ea5a4d26 61 fields · synced Oct 7, 2026