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Ultrasonic Surgical Shears
EUDAMEDClass IIb (EU MDR)
Ref AH-639-O-CModel AH-639-O-C, AH-639-L-C, AH-639-S-C, AH-639-T-C
Identity
- Trade Name
- Ultrasonic Surgical Shears EUDAMED
- Device Name
- Ultrasonic Surgical Shears EUDAMED
- Model / Reference
- AH-639-O-C, AH-639-L-C, AH-639-S-C, AH-639-T-C EUDAMEDAH-639-O-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970950280675 EUDAMED
- Basic UDI-DI
- 6970950282b001AS EUDAMED
- Direct Marketing DI
- 06970950280675 EUDAMED
- EMDN Code
- K0202010102 LAPAROSCOPIC AND THORACOSCOPIC ULTRASONIC 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 | 6970950282b001AS | 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 40d64f6f-bb9c-457b-b803-bd53870c9487 61 fields · synced Jun 19, 2026