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Amts
EUDAMEDClass IIa (EU MDR)
Ref WTNR-01Ref WD-01ENRef WTNR-09Ref WD-01NNRef esteticPen by LABODERMRef WTNR-12FRef 08.701Ref WTNR-07Ref CODE-XMRef NEEDLEShapeRef WD-06Ref PENShapeRef WTNR-16SRef WTNR-05Ref WD-03ENRef WD-03Ref RaffneRef WD-04Ref WTNR-12SRef WD-MAGNUMRef WD-09Ref Pro-Stamp
Identity
- Device Name
- AMTS EUDAMED
- Model / Reference
- WTNR-01 EUDAMEDWD-01EN EUDAMEDWTNR-09 EUDAMEDWD-01NN EUDAMEDesteticPen by LABODERM EUDAMEDWTNR-12F EUDAMED08.701 EUDAMEDWTNR-07 EUDAMEDCODE-XM EUDAMEDNEEDLEShape EUDAMEDWD-06 EUDAMEDPENShape EUDAMEDWTNR-16S EUDAMEDWTNR-05 EUDAMEDWD-03EN EUDAMEDWD-03 EUDAMEDRaffne EUDAMEDWD-04 EUDAMEDWTNR-12S EUDAMEDWD-MAGNUM EUDAMEDWD-09 EUDAMEDPro-Stamp EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800118100119 EUDAMED08800118100225 EUDAMED08800118100188 EUDAMED08800118100218 EUDAMED08800118100386 EUDAMED08800118100454 EUDAMED08800118100492 EUDAMED08800118100171 EUDAMED08800118100362 EUDAMED08800118100539 EUDAMED08800118100270 EUDAMED08800118100393 EUDAMED08800118100485 EUDAMED08800118100157 EUDAMED08800118100249 EUDAMED08800118100232 EUDAMED08800118100003 EUDAMED08800118100256 EUDAMED08800118100478 EUDAMED08800118100294 EUDAMED08800118100287 EUDAMED08800118100379 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
EUDAMEDEUDAMED
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 (22)
- EUDAMED 0a42b2cc-e0ea-4367-98e8-2cf7a984fa14 61 fields · synced Aug 4, 2026
- EUDAMED d40d2af7-e5ed-4892-97a1-66fc153cba40 61 fields · synced May 16, 2026
- EUDAMED 3270cda4-b254-4e0c-8218-c03aa07cafdd 61 fields · synced May 16, 2026
- EUDAMED c52b1fd7-e666-4128-92f9-91b5f0cf2919 61 fields · synced May 17, 2026
- EUDAMED 0d44d27d-0c97-4947-a97f-ff3848220a06 61 fields · synced May 17, 2026
- EUDAMED c215996d-e39f-42a2-90b0-6d61b40a792c 61 fields · synced May 17, 2026
- EUDAMED 55305ab2-d345-4134-9fd9-d2ae7e4b1230 61 fields · synced May 17, 2026
- EUDAMED 956a67f9-24d8-46a1-b625-d3a211f6e8f9 61 fields · synced May 18, 2026
- EUDAMED 960e88f9-752b-469c-b7b5-4431db805cf9 61 fields · synced May 18, 2026
- EUDAMED a90455f5-b193-4e16-9e21-53c13c417c83 61 fields · synced May 18, 2026
- EUDAMED 9e673a8b-0879-44d8-be79-55bbf525581c 61 fields · synced May 18, 2026
- EUDAMED 6ca03469-507c-4e39-a5d2-3ea6378ffcdf 61 fields · synced May 18, 2026
- EUDAMED 5caf9c8c-0afc-47c0-891d-ba4a21471a6b 61 fields · synced May 18, 2026
- EUDAMED d8eddd56-1cac-4e7a-b709-05f42fd05869 61 fields · synced May 18, 2026
- EUDAMED ec1a9e8c-fdf8-404b-b444-b541eaa33e2b 61 fields · synced May 18, 2026
- EUDAMED cf00729e-3b57-4c6e-bce3-6465bf60e35e 61 fields · synced May 18, 2026
- EUDAMED 563d9713-0643-436f-bcfb-3c28f287a848 61 fields · synced May 18, 2026
- EUDAMED 1547abb8-ae7b-416a-9105-ba7d15d33c01 61 fields · synced May 18, 2026
- EUDAMED 07d4adf0-1c7a-4d38-9dba-73a830a0fe2d 61 fields · synced May 18, 2026
- EUDAMED dc77313e-798e-421b-a7bc-e5f41dfa14b0 61 fields · synced May 19, 2026
- EUDAMED ef6dec78-f13a-4983-b8e5-6084b4a9d3a6 61 fields · synced May 19, 2026
- EUDAMED c215343a-559a-49b2-90dd-203db8f50048 61 fields · synced May 19, 2026