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Sterilization Pouch
EUDAMEDClass I (EU MDR)
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Identity
- Trade Name
- Sterilization Pouch EUDAMED
- Device Name
- Self-Sealing Sterilization Pouch & Sterilization Reel EUDAMED
- Model / Reference
- HD-228380 EUDAMEDHD-190330 EUDAMEDHD-90135 EUDAMEDHD-305430 EUDAMEDHD-57130 EUDAMEDHD-135260 EUDAMEDHD-140310 EUDAMEDHD-135280 EUDAMEDHD-70230 EUDAMEDHD-90230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974321449074 EUDAMED06974321449067 EUDAMED06974321449036 EUDAMED06974321449081 EUDAMED06974321449197 EUDAMED06974321449050 EUDAMED06974321449258 EUDAMED06974321449241 EUDAMED06974321449029 EUDAMED06974321449043 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 (10)
- EUDAMED 0df071cf-18a9-4684-92bc-76ab6325a15b 61 fields · synced Oct 7, 2026
- EUDAMED fdc17149-e4bb-44fd-9b1d-60692345c748 61 fields · synced May 16, 2026
- EUDAMED 6b12819b-6fe6-4a32-b46d-e977cdb1ea12 61 fields · synced May 17, 2026
- EUDAMED 4a8c44f2-a9c3-427e-b289-468424cb02b5 61 fields · synced May 17, 2026
- EUDAMED 68e8f8dc-6e6c-4bdc-8fba-184d64bb7a58 61 fields · synced May 17, 2026
- EUDAMED 8dc2646b-5744-43ae-9531-13f76c5b039b 61 fields · synced May 18, 2026
- EUDAMED 6e6c412a-16a8-4266-86b2-fe33ed47d1af 61 fields · synced May 18, 2026
- EUDAMED 9a27090f-d911-4a52-98ad-e1778d3066cc 61 fields · synced May 18, 2026
- EUDAMED 52d47594-1031-40da-a311-58183b825476 61 fields · synced May 18, 2026
- EUDAMED 5a66f1df-c80b-4642-827e-0959f6303d9e 61 fields · synced May 19, 2026