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Single Use Electrosurgical Knife
EUDAMEDClass IIb (EU MDR)
Ref EK-401DRef EK-402DRef EK-427DRef EK-415DRef EK-425DRef EK-403DRef EK-411DRef EK-426DRef EK-408DRef EK-424DRef EK-420DRef EK-419DRef EK-414DRef EK-404DRef EK-428DRef EK-429DRef EK-407DRef EK-422DRef EK-430D
Identity
- Trade Name
- Single Use Electrosurgical Knife EUDAMED
- Device Name
- Single Use Electrosurgical Knife EUDAMED
- Model / Reference
- EK-401D EUDAMEDEK-402D EUDAMEDEK-427D EUDAMEDEK-415D EUDAMEDEK-425D EUDAMEDEK-403D EUDAMEDEK-411D EUDAMEDEK-426D EUDAMEDEK-408D EUDAMEDEK-424D EUDAMEDEK-420D EUDAMEDEK-419D EUDAMEDEK-414D EUDAMEDEK-404D EUDAMEDEK-428D EUDAMEDEK-429D EUDAMEDEK-407D EUDAMEDEK-422D EUDAMEDEK-430D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948318947713 EUDAMED06948318947720 EUDAMED06948318947966 EUDAMED06948318947843 EUDAMED06948318947942 EUDAMED06948318928422 EUDAMED06948318947805 EUDAMED06948318947959 EUDAMED06948318947775 EUDAMED06948318947935 EUDAMED06948318947898 EUDAMED06948318947881 EUDAMED06948318947836 EUDAMED06948318947737 EUDAMED06948318947973 EUDAMED06948318947980 EUDAMED06948318947768 EUDAMED06948318947911 EUDAMED06948318947997 EUDAMED
- Basic UDI-DI
- 694831892b005ML EUDAMED
- Direct Marketing DI
- 06948318947713 EUDAMED06948318947720 EUDAMED
- EMDN Code
- G030299 DIGESTIVE ENDOSCOPY, HAEMOSTASIS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Single Use Electrosurgical Knife by Anrei Medical (HZ) 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 | 694831892b005ML | Class IIb | Active |
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Manufacturer
- Manufacturer
- Anrei Medical (HZ) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009964
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (21)
- EUDAMED b2077dd2-4378-4c1c-9905-8ca1babe9213 61 fields · synced Sep 17, 2026
- EUDAMED 5160af8f-0c99-4f26-a5c2-2f003617c379 61 fields · synced May 19, 2026
- EUDAMED d94aecc4-7628-4826-9730-50f7973da61b 61 fields · synced Jun 18, 2026
- EUDAMED ab4e491c-ca60-4d95-bf45-c869630ee315 61 fields · synced Jun 18, 2026
- EUDAMED 3a24db67-a9e3-494f-8fd8-3a4f7136ee09 61 fields · synced Jun 18, 2026
- EUDAMED 1aea2910-9f36-474d-8f13-e80ec4da1ee9 61 fields · synced Jun 20, 2026
- EUDAMED f1e66c0f-cfbc-451d-a0b6-dbd8c6ccbecc 61 fields · synced Jun 20, 2026
- EUDAMED 5b529947-2f5b-4d11-a9fb-9b7bd0f80270 61 fields · synced Jul 10, 2026
- EUDAMED 9aeca89a-c1e2-46d4-b320-031ab67ad830 61 fields · synced Jul 11, 2026
- EUDAMED 103726c8-5864-4b6b-8bf9-8a42a57caad4 61 fields · synced Jul 11, 2026
- EUDAMED ac8882d2-be4d-44d4-b021-b457821e4a7d 61 fields · synced Jul 14, 2026
- EUDAMED e762db73-826f-458c-85e1-bb9d461e31ba 61 fields · synced Jul 14, 2026
- EUDAMED ccf21aae-e297-4f5e-a9f6-476faf66f811 61 fields · synced Jul 14, 2026
- EUDAMED f401cd08-feb3-42e5-9ab9-d64ba1d0a485 61 fields · synced Jul 14, 2026
- EUDAMED 5f266991-87ef-4777-a473-ec4b6978a2ca 61 fields · synced Jul 19, 2026
- EUDAMED f1d4c62c-7f4a-4b94-81f2-bc131326360b 61 fields · synced Jul 19, 2026
- EUDAMED 67d3bea3-947f-440e-8b71-fec788187309 61 fields · synced Jul 24, 2026
- EUDAMED 9b4c2a19-83b3-42a3-96d4-5f22bf216ff5 61 fields · synced Jul 25, 2026
- EUDAMED 534f24c9-202f-42d8-8d78-1948b8d6c7f1 61 fields · synced Jul 26, 2026
- EUDAMED e78d11b3-adc4-4709-a310-3d9c1a20d76a 61 fields · synced Jul 27, 2026
- EUDAMED f16001f3-cd34-44ad-b192-716bbd55528e 61 fields · synced Sep 17, 2026