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Disposable Ultrasonic Shear
EUDAMEDClass IIb (EU MDR)
Ref NoModel UK-I-14, UK-I-23, UK-I-36, UK-I-45
Identity
- Device Name
- Disposable Ultrasonic Shear EUDAMED
- Model / Reference
- UK-I-14, UK-I-23, UK-I-36, UK-I-45 EUDAMEDNo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957138611513 EUDAMED
- Basic UDI-DI
- 69571386UD20W4 EUDAMED
- EMDN Code
- K0202010101,K0202010102 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Disposable Ultrasonic Shear by Tianjin Huahong Technology Co., Ltd. — Class IIb — 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 | 69571386UD20W4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Tianjin Huahong Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015849
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 71a42692-5da9-43b7-9a5a-c6d8ebc4c2f7 61 fields · synced Jun 19, 2026