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Ultrasonic Surgical Shears
EUDAMEDClass IIb (EU MDR)
Ref AH-639-OModel AH-639-O, AH-639-L, AH-639-S, AH-639-TRef AH-639-L-CModel AH-639-O-C, AH-639-L-C, AH-639-S-C, AH-639-T-CRef AH-638-B-L-CModel AH-638-B-O-C, AH-638-B-L-C, AH-638-S-C, AH-638-B-T-CRef AH-638-B-O-CRef AH-639-TRef AH-639-S-CRef AH-639-T-C
Identity
- Trade Name
- Ultrasonic Surgical Shears EUDAMED
- Device Name
- Ultrasonic Surgical Shears EUDAMED
- Model / Reference
- AH-639-O, AH-639-L, AH-639-S, AH-639-T EUDAMEDAH-639-O EUDAMEDAH-639-O-C, AH-639-L-C, AH-639-S-C, AH-639-T-C EUDAMEDAH-639-L-C EUDAMEDAH-638-B-O-C, AH-638-B-L-C, AH-638-S-C, AH-638-B-T-C EUDAMEDAH-638-B-L-C EUDAMEDAH-638-B-O-C EUDAMEDAH-639-T EUDAMEDAH-639-S-C EUDAMEDAH-639-T-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970950280637 EUDAMED06970950280651 EUDAMED06970950280743 EUDAMED06970950280767 EUDAMED06970950280644 EUDAMED06970950280668 EUDAMED06970950280682 EUDAMED
- Basic UDI-DI
- 6970950282b007B6 EUDAMED6970950282b001AS EUDAMED6970950282b006B4 EUDAMED
- Direct Marketing DI
- 06970950280637 EUDAMED06970950280651 EUDAMED06970950280743 EUDAMED06970950280767 EUDAMED06970950280644 EUDAMED06970950280668 EUDAMED06970950280682 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
EUDAMEDEUDAMED
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 | 6970950282b007B6 | 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 (7)
- EUDAMED 7f46d647-566f-4c70-8ef3-980f70796b6a 61 fields · synced Jul 27, 2026
- EUDAMED 51356514-a4e5-459e-9816-c523cacf7f77 61 fields · synced May 16, 2026
- EUDAMED 881aa916-9aaf-40ce-bc92-e9de34a82684 61 fields · synced May 17, 2026
- EUDAMED e2266c05-25b3-4d44-8300-99815be0af5d 61 fields · synced May 17, 2026
- EUDAMED 14501526-9de9-4b0f-ac1c-8212999104d3 61 fields · synced May 18, 2026
- EUDAMED bda0881e-c9f8-4447-adcc-b50ab574c96f 61 fields · synced May 18, 2026
- EUDAMED 5261ee17-b4de-43da-912e-75798883c65e 61 fields · synced May 19, 2026