Identity
- Trade Name
- Dotomy EUDAMED
- Device Name
- Dotomy EUDAMED
- Model / Reference
- SW-TW-02 EUDAMEDSW-TW-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809272563990 EUDAMED08809272563983 EUDAMED
- Basic UDI-DI
- B-08809272563990 EUDAMEDB-08809272563983 EUDAMED
- EMDN Code
- Z121301 PERCUTANEOUS DISCECTOMY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Dotomy by Seawon Meditech Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08809272563990 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Seawon Meditech Co., Ltd.
- EUDAMED SRN
- KR-MF-000007442
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a7edaf1b-77b6-411a-9d23-aaaee2142a2e 61 fields · synced Jul 28, 2026
- EUDAMED 4657f15f-a335-42e0-817f-3b2563eafaf7 61 fields · synced May 18, 2026