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Electrosurgical Vessel Sealer/Divider
EUDAMEDClass IIb (EU MDR)
Ref AH-163XP-44SModel AH-16319-23, AH-16319-37, AH-16319-44, AH-163XP-23S, AH-163XP-37S, AH-163XP-44S, AH-163XP-23L, AH-163XP-37L, AH-163XP-44L, AH-1637-21
Identity
- Device Name
- Electrosurgical Vessel Sealer/Divider EUDAMED
- Model / Reference
- AH-16319-23, AH-16319-37, AH-16319-44, AH-163XP-23S, AH-163XP-37S, AH-163XP-44S, AH-163XP-23L, AH-163XP-37L, AH-163XP-44L, AH-1637-21 EUDAMEDAH-163XP-44S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970950282334 EUDAMED
- Basic UDI-DI
- 6970950282b014B3 EUDAMED
- EMDN Code
- K0201010201,K0201010202 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Electrosurgical Vessel Sealer/Divider 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 | 6970950282b014B3 | 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 7c57737b-1e9e-4892-b54c-db627724948d 61 fields · synced Jun 20, 2026