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Multi-unit Plastic Cylinder
EUDAMEDClass I (EU MDR)
Ref AMPC100HC Ref AMPC450SC Ref AMPC450HC Ref MPC100Ref AMPC100SRef AMPC450S Ref AMPC550S Ref AMPC550HC
Identity
- Trade Name
- Multi-unit Plastic Cylinder EUDAMED
- Device Name
- IH IMPLANT SYSTEM / Laboratory components & Etc. EUDAMED
- Model / Reference
- AMPC100HC EUDAMEDAMPC450SC EUDAMEDAMPC450HC EUDAMEDMPC100 EUDAMEDAMPC100S EUDAMEDAMPC450S EUDAMEDAMPC550S EUDAMEDAMPC550HC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041355860 EUDAMED08800041355921 EUDAMED08800041355884 EUDAMED08800041355747 EUDAMED08800041355822 EUDAMED08800041355846 EUDAMED08800041355853 EUDAMED08800041355891 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 Plastic Cylinder 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 (8)
- EUDAMED b04dd0eb-3f62-4bcc-9d7a-0aa246932921 61 fields · synced Aug 2, 2026
- EUDAMED 64d42cc7-c479-4f01-89ea-bd00c88eeefe 61 fields · synced May 17, 2026
- EUDAMED a0b128f3-bb10-4acd-a899-e7661e6c8aa7 61 fields · synced May 17, 2026
- EUDAMED be4f36f4-6f15-4d94-aeda-f3b45a5b9d3f 61 fields · synced May 17, 2026
- EUDAMED cfb225cd-1708-4a6d-958b-2eaa72531a23 61 fields · synced May 17, 2026
- EUDAMED b26421b4-3884-4c98-90c5-24b23ad2837f 61 fields · synced May 18, 2026
- EUDAMED 35b02c87-5f45-42d0-8852-68f50905dbc0 61 fields · synced May 18, 2026
- EUDAMED c54ef7fe-fead-4d1b-b55d-1a08c85eadf4 61 fields · synced May 19, 2026