Identity
- Device Name
- AMTS EUDAMED
- Model / Reference
- 08.703 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800118100515 EUDAMED
- Basic UDI-DI
- 88001181AMTSMC EUDAMED
- EMDN Code
- A019006 MESOTHERAPY NEEDLES EUDAMED
Classification
- Device Class
- Class IIa 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
Amts by Woorhi Mechatronics Co., Ltd. — Class IIa — 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 | 88001181AMTSMC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Woorhi Mechatronics Co., Ltd.
- EUDAMED SRN
- KR-MF-000035848
- Authorised Representative
- SMB EUROPE SAS FR-AR-000011981
Sources (1)
- EUDAMED f046fd93-90ef-44fc-8ffb-b50e80d40636 61 fields · synced Jun 18, 2026