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InSeal Sealer/Divider
EUDAMEDClass IIb (EU MDR)
Ref EG1124-CFModel EG1124,EG1138,EG1145, EG1124-C,EG1138-C,EG1145-C, EG1124-F,EG1138-F,EG1145-F, EG1124-CF EG1138-CF,EG1145-CF,EG2124,EG2138,EG2145, EG2124-C,EG2138-C,EG2145-C, EG2124-F,EG2138-F,EG2145-F, EG2124-CF EG2138-CF,EG2145-CF,EG3122, EG3122-C,EH1119,EH1119-C
Identity
- Trade Name
- InSeal Sealer/Divider EUDAMED
- Device Name
- InSeal Sealer/Divider EUDAMED
- Model / Reference
- EG1124,EG1138,EG1145, EG1124-C,EG1138-C,EG1145-C, EG1124-F,EG1138-F,EG1145-F, EG1124-CF EG1138-CF,EG1145-CF,EG2124,EG2138,EG2145, EG2124-C,EG2138-C,EG2145-C, EG2124-F,EG2138-F,EG2145-F, EG2124-CF EG2138-CF,EG2145-CF,EG3122, EG3122-C,EH1119,EH1119-C EUDAMEDEG1124-CF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464945644 EUDAMED
- Basic UDI-DI
- 697246494MD03200ISD001XE EUDAMED
- EMDN Code
- K0299 ELECTROSURGERY DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Category: Percutaneous radio-frequency ablation system generator
InSeal Sealer/Divider by Innolcon Medical Technology (Suzhou) Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Percutaneous radio-frequency ablation system generator.
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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 | 697246494MD03200ISD001XE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Innolcon Medical Technology (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012689
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9263f65a-e4ea-4b70-813f-a5bedd9d9c35 61 fields · synced Jun 19, 2026