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Soft-tissue Ultrasonic Surgical System Handpiece Tips for Single Use
EUDAMEDClass IIb (EU MDR)
Ref AH-638-B-S
Identity
- Trade Name
- Soft-tissue Ultrasonic Surgical System Handpiece Tips for Single Use EUDAMED
- Device Name
- Soft-tissue Ultrasonic Surgical System Handpiece Tips for Single Use EUDAMED
- Model / Reference
- AH-638-B-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970950280163 EUDAMED
- Basic UDI-DI
- B-06970950280163 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970950280163 | 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 3f15afb8-04cf-403f-b7de-b7f6286f0d6a 61 fields · synced Jun 19, 2026