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SOUND REACH PD Shears
EUDAMEDClass IIb (EU MDR)
Ref CH23PDModel CH14PD, CH23PD, CH36PD, CH45PDRef CH14PDRef CH36PD
Identity
- Trade Name
- SOUND REACH PD Shears EUDAMED
- Device Name
- Disposable Ultrasonic Scalpels EUDAMED
- Model / Reference
- CH14PD, CH23PD, CH36PD, CH45PD EUDAMEDCH23PD EUDAMEDCH14PD EUDAMEDCH36PD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815802250 EUDAMED06953815802243 EUDAMED06953815802267 EUDAMED
- Basic UDI-DI
- 69538158F107PX EUDAMED
- EMDN Code
- K0202010102 LAPAROSCOPIC AND THORACOSCOPIC ULTRASONIC SURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 PD 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 | 69538158F107PX | 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 (3)
- EUDAMED 5870969e-4568-4ec6-9941-6c0faecc804c 61 fields · synced Oct 6, 2026
- EUDAMED 1b171d01-f3fe-400c-bf6f-ccfda393bf1e 61 fields · synced May 17, 2026
- EUDAMED 7dda9e84-9dd2-4cc6-bb55-e4cb2e3d2289 61 fields · synced May 19, 2026