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Ultrasonic Surgical Shears

EUDAMED

Class IIb (EU MDR)

Ref AH-631-SModel AH-631-O, AH-631-L, AH-631-S, AH-631-T

by Affacare Medical (Beijing) Co., Ltd.

Identity

Trade Name
Ultrasonic Surgical Shears EUDAMED
Soft-tissue Ultrasonic Surgical System Handpiece Tips for Single Use EUDAMED
Device Name
Ultrasonic Surgical Shears EUDAMED
Soft-tissue Ultrasonic Surgical System Handpiece Tips for Single Use EUDAMED
Model / Reference
AH-631-O, AH-631-L, AH-631-S, AH-631-T EUDAMED
AH-631-S EUDAMED

Identifiers

Primary DI / UDI-DI
06970950280071 EUDAMED
Basic UDI-DI
6970950282b008B8 EUDAMED
B-06970950280071 EUDAMED
Direct Marketing DI
06970950280071 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Affacare Medical (Beijing) Co., Ltd.
EUDAMED SRN
CN-MF-000025388
Authorised Representative
Prolinx GmbH DE-AR-000005129

Sources (2)

  • EUDAMED 8490e3a7-7176-4d16-bc6e-00b24d077ea5 61 fields · synced Jun 19, 2026
  • EUDAMED 6c8de54d-10e7-4e56-bd45-d3b7c787fe3e 61 fields · synced May 17, 2026