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Multi-unit Transfer Impression Coping
EUDAMEDClass I (EU MDR)
Ref AMTIC100HRef MTIC550 Ref AMTIC450 Ref MTIC450 Ref MTIC200 Ref AMTIC200H Ref MTICS70S
Identity
- Trade Name
- Multi-unit Transfer Impression Coping EUDAMED
- Device Name
- IH IMPLANT SYSTEM / Laboratory components & Etc. EUDAMED
- Model / Reference
- AMTIC100H EUDAMEDMTIC550 EUDAMEDAMTIC450 EUDAMEDMTIC450 EUDAMEDMTIC200 EUDAMEDAMTIC200H EUDAMEDMTICS70S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041356294 EUDAMED08800041356249 EUDAMED08800041356270 EUDAMED08800041356232 EUDAMED08800041356263 EUDAMED08800041356317 EUDAMED08800041356355 EUDAMED
- Basic UDI-DI
- 8800041300003014W EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
Multi-unit Transfer Impression Coping by SEWONMEDIX Inc. — Class I — 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 | 8800041300003014W | Class I | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (7)
- EUDAMED a95b5f8a-1a26-4142-9a0b-2fbe8904cbba 61 fields · synced Sep 18, 2026
- EUDAMED d1151dbd-f6d7-4738-904b-67e7150ae482 61 fields · synced May 16, 2026
- EUDAMED 40d791cb-7f36-4491-8df2-794981ad0224 61 fields · synced May 17, 2026
- EUDAMED c247b3e0-5318-4be5-9d2f-4cbb50b49e1a 61 fields · synced May 17, 2026
- EUDAMED 70575858-1c7a-4447-9037-c84d5458a526 61 fields · synced May 18, 2026
- EUDAMED 9055a88f-cbca-4b68-be3d-0154a5d74587 61 fields · synced May 19, 2026
- EUDAMED 3439249d-1e75-40b0-8595-e3b87bd46583 61 fields · synced May 19, 2026