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Elastic Bandage
EUDAMEDClass I (EU MDR)
Ref N/AModel 2.5cm*4.5m，5cm*4.5m，7.5cm*4.5m，10cm*4.5m，15cm*4.5m
Identity
- Device Name
- Elastic Bandage EUDAMED
- Model / Reference
- 2.5cm*4.5m，5cm*4.5m，7.5cm*4.5m，10cm*4.5m，15cm*4.5m EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973861260057 EUDAMED
- Basic UDI-DI
- 697386126Bandage001BK EUDAMED
- EMDN Code
- M03030299 PROTECTION SYSTEMS - OTHER 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
Yes
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
Category: Cast/bandage waterproof bathing cover, reusable
Elastic Bandage by Wenzhou Zhusi Medical Supplies Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cast/bandage waterproof bathing cover, reusable.
- Flexible Waterproof Bandages — HUBEI DECEN BIOTECHNOLOGY CO., LTD · Class I
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- cast padding — Anji Hengfeng Sanitary Material Co., Ltd · Class I
- Medical Compression Hosiery for Varices — Zhejiang Tuo zhen Medical Technology Co., Ltd. · Class I
- Seal-Tight — BROWNMED, INC. · Class I
- PLASTER OF PARIS BANDAGE — ANJI YAOHUI MEDICAL PRODUCTS CO., LTD. · Class I
- Transparent tape — Jiangsu Nanfang Medical Co., Ltd. · Class I
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 | 697386126Bandage001BK | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Zhusi Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000034311
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a33c7b97-53a5-4ab0-b835-ae23dfebab57 61 fields · synced Jun 20, 2026