Identity
- Trade Name
- Sterilization Pouch EUDAMED
- Device Name
- Self-Sealing Sterilization Pouch & Sterilization Reel EUDAMED
- Model / Reference
- HD-70260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974321449203 EUDAMED
- Basic UDI-DI
- 697432144SP001F9 EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, 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 Pouch by Jiujiang HuaDa Medical Dressing Co., Ltd. — 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 | 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 a9a52678-c62e-4b77-9924-83e3a5540bb6 61 fields · synced Jun 18, 2026