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SOUND REACH H Shears
EUDAMEDClass IIb (EU MDR)
Ref CS1405HModel CS1405H, CS2305H, CS3605H, CS4505H, CS1405F, CS2305F, CS3605F, CS4505F
Identity
- Trade Name
- SOUND REACH H Shears EUDAMED
- Device Name
- Disposable Ultrasonic Scalpels EUDAMED
- Model / Reference
- CS1405H, CS2305H, CS3605H, CS4505H, CS1405F, CS2305F, CS3605F, CS4505F EUDAMEDCS1405H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815802236 EUDAMED
- Basic UDI-DI
- 69538158F732W EUDAMED
- EMDN Code
- K0202010102 LAPAROSCOPIC AND THORACOSCOPIC ULTRASONIC SURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece 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
SOUND REACH H Shears by Reach Surgical, Inc. — 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 | 69538158F732W | Class IIb | Active |
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Manufacturer
- Manufacturer
- Reach Surgical, Inc.
- EUDAMED SRN
- CN-MF-000011148
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED d4aaf83f-707a-425a-a2e9-91f0ce99b945 61 fields · synced Jun 18, 2026