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Soft-tissue Ultrasonic Surgical System Handpiece Tips for Single Use

EUDAMED

Class IIb (EU MDR)

Ref AH-638-B-LModel AH-638-B-L, AH-638-B-S, AH-638-B-T

by Affacare Medical (Beijing) Co., Ltd.

Identity

Trade Name
Soft-tissue Ultrasonic Surgical System Handpiece Tips for Single Use EUDAMED
Ultrasonic Surgical Shears EUDAMED
Device Name
Soft-tissue Ultrasonic Surgical System Handpiece Tips for Single Use EUDAMED
Ultrasonic Surgical Shears EUDAMED
Model / Reference
AH-638-B-L EUDAMED
AH-638-B-L, AH-638-B-S, AH-638-B-T EUDAMED

Identifiers

Primary DI / UDI-DI
06970950280156 EUDAMED
Basic UDI-DI
B-06970950280156 EUDAMED
6970950282b009BA EUDAMED
Direct Marketing DI
06970950280156 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

Soft-tissue Ultrasonic Surgical System Handpiece Tips for Single Use by Affacare Medical (Beijing) Co., Ltd. — Class IIb — MDR, MDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

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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 ff7af15c-7ea9-435b-b361-a82e63529611 61 fields · synced Jul 26, 2026
  • EUDAMED 08f7525a-68b8-419e-959c-4157446d2191 61 fields · synced May 18, 2026