Identity
- Trade Name
- CP-16 TIP EUDAMED
- Device Name
- CP-16 TIP EUDAMED
- Model / Reference
- CP-16 TIP EUDAMEDCP-16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800020107558 EUDAMED
- Basic UDI-DI
- B-08800020107558 EUDAMED
- EMDN Code
- K020380 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
Category: Radio-frequency ablation system
Cp-16 Tip by Jeisys Medical Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency ablation system.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Cavi di connessione — ADVANCED MEDICAL SYSTEMS GROUP S.R.L. · Class I
- RF Ablation Electrode Kits — SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. · Class IIb
- 10THERMA Electrode — TENTECH Inc. · Class IIb
- Acessa ProVu PFG Table Clamp — ACESSA HEALTH INC. · Class II
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Acessa ProVu System — ACESSA HEALTH INC. · Class II
- Acessa ProVu Dual Foot Pedal — ACESSA HEALTH INC. · Class II
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-08800020107558 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jeisys Medical Inc.
- EUDAMED SRN
- KR-MF-000008513
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED ddbe5e05-6c66-4267-a41d-1230b4e78a89 61 fields · synced Jul 9, 2026