Identity
- Trade Name
- A1-12 TIP EUDAMED
- Device Name
- A1-12 TIP EUDAMED
- Model / Reference
- A1-12 TIP EUDAMEDA1-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800020107565 EUDAMED
- Basic UDI-DI
- B-08800020107565 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
A1-12 Tip by Jeisys Medical Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08800020107565 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jeisys Medical Inc.
- EUDAMED SRN
- KR-MF-000008513
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED afd25fc7-8d18-4480-80da-f79c52657844 61 fields · synced Jul 8, 2026