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Sterilization Reel
EUDAMEDClass I (EU MDR)
Ref HD-R350200Ref HD-R250200Ref HD-R300200Ref HD-R75200Ref HD-R400200Ref HD-R55200Ref HD-R50200Ref HD-R100200Ref HD-R200200
Identity
- Trade Name
- Sterilization Reel EUDAMED
- Device Name
- Self-Sealing Sterilization Pouch & Sterilization Reel EUDAMED
- Model / Reference
- HD-R350200 EUDAMEDHD-R250200 EUDAMEDHD-R300200 EUDAMEDHD-R75200 EUDAMEDHD-R400200 EUDAMEDHD-R55200 EUDAMEDHD-R50200 EUDAMEDHD-R100200 EUDAMEDHD-R200200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974321449173 EUDAMED06974321449159 EUDAMED06974321449166 EUDAMED06974321449111 EUDAMED06974321449180 EUDAMED06974321449104 EUDAMED06974321449098 EUDAMED06974321449128 EUDAMED06974321449142 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 — 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 (9)
- EUDAMED 7a33ce1d-6a09-4bd1-b4ae-8ce619824090 61 fields · synced Oct 6, 2026
- EUDAMED f0b9729b-d8e4-41e6-90a8-8cec354678af 61 fields · synced May 17, 2026
- EUDAMED 34e401e9-0587-492e-aae9-66960765a3cf 61 fields · synced May 17, 2026
- EUDAMED fa86a19f-8dd2-4992-8e42-83a411283980 61 fields · synced May 18, 2026
- EUDAMED 1a2dd328-be71-49f9-8fc0-3279cd7f6a07 61 fields · synced May 18, 2026
- EUDAMED 359f1a68-3e67-491e-abfc-d3150451dfc7 61 fields · synced May 18, 2026
- EUDAMED 362ab110-da5f-47a1-a285-131cc70726c8 61 fields · synced May 18, 2026
- EUDAMED 8134848d-aa7c-4991-a0f6-b3898a71aa38 61 fields · synced May 19, 2026
- EUDAMED e9b7338e-1bac-462c-a8c0-eea9ea5a4d26 61 fields · synced May 19, 2026