Identity
- Trade Name
- Ultrasonic Surgical Shears EUDAMED
- Device Name
- Ultrasonic Surgical Shears EUDAMED
- Model / Reference
- AH-637-9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970950280699 EUDAMED
- Basic UDI-DI
- 6970950282b010AT EUDAMED
- Direct Marketing DI
- 06970950280699 EUDAMED
- EMDN Code
- K0202010101 ULTRASONIC OPEN SURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Ultrasonic Surgical Shears by Affacare Medical (Beijing) 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 | 6970950282b010AT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Affacare Medical (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025388
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED fa102d8d-0770-48a2-aa7d-31a6a85b6b51 61 fields · synced Jun 19, 2026