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Multi-unit Pick-up Impression Coping
EUDAMEDFDA UDIClass I (EU MDR)
Ref AMPIC100H
Identity
- Trade Name
- Multi-unit Pick-up Impression Coping EUDAMEDMulti-unit Pick-up Impression Coping Body + Guide Pin FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- IH IMPLANT SYSTEM / Laboratory components & Etc. EUDAMEDSEWON MEDIX IH Multi-unit Pick-up Impression Coping Class I Body Bridge(was MPIC480) Set Product, Ø4.8x8.0mm FDA UDI
- Model / Reference
- AMPIC100H EUDAMEDFDA UDI
- Description
- SEWON MEDIX IH Multi-unit Pick-up Impression Coping Class I Body Bridge(was MPIC480) Set Product, Ø4.8x8.0mm FDA UDI
Identifiers
- Catalog Number
- AMPIC100H FDA UDI
- Primary DI / UDI-DI
- 08800041356409 EUDAMEDFDA UDI
- Basic UDI-DI
- 8800041300003014W EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Multi-unit Pick-up Impression Coping by SEWONMEDIX Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8800041300003014W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED cba299ae-0c3e-4142-a419-1fb3d5c7cae3 61 fields · synced Jul 9, 2026
- FDA UDI 502f2cfd-0312-4d64-b446-7b596f0b0392 36 fields · synced May 30, 2026