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Electrosurgical Vessel Sealer/Divider
EUDAMEDClass IIb (EU MDR)
Ref AH-1637-21Model 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-1637-21Ref AH-16319-23Ref AH-163XP-37SRef AH-16319-44Ref AH-163XP-23SRef AH-163XP-44LRef AH-163XP-23LRef AH-163XP-37L
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-1637-21 EUDAMEDAH-16319-23 EUDAMEDAH-163XP-37S EUDAMEDAH-16319-44 EUDAMEDAH-163XP-23S EUDAMEDAH-163XP-44L EUDAMEDAH-163XP-23L EUDAMEDAH-163XP-37L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970950282273 EUDAMED06970950281597 EUDAMED06970950282327 EUDAMED06970950281610 EUDAMED06970950282310 EUDAMED06970950282303 EUDAMED06970950282280 EUDAMED06970950282297 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 (8)
- EUDAMED 9d9a278e-2615-4608-b206-fa78fa18d78e 61 fields · synced Sep 30, 2026
- EUDAMED cef02723-8bb4-47c2-9893-47aaeed00970 61 fields · synced May 16, 2026
- EUDAMED bda183f8-2d2c-4768-a1a2-deb4bb5668a5 61 fields · synced May 16, 2026
- EUDAMED 9b7eb7b5-c5a9-4469-b467-0088dafafd45 61 fields · synced May 17, 2026
- EUDAMED 764e8397-6288-4ed1-94e2-5bd6ed1d2fe0 61 fields · synced May 17, 2026
- EUDAMED 653a97c1-7c11-491a-8e55-0b9436c247df 61 fields · synced May 17, 2026
- EUDAMED 6f7fc84b-6563-49f6-8a43-1fd64025df94 61 fields · synced May 18, 2026
- EUDAMED 34146b33-fc2c-4031-9af7-905904100c4a 61 fields · synced May 18, 2026