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Hollenback Amalgam Instruments
EUDAMEDClass I (EU MDR)
Ref IMC62101Model IMC62101 to IMC62123
Identity
- Trade Name
- Hollenback Amalgam Instruments EUDAMED
- Device Name
- Amalgam Instruments EUDAMED
- Model / Reference
- IMC62101 to IMC62123 EUDAMEDIMC62101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G375IMC6210105 EUDAMED
- Basic UDI-DI
- ++G375IMC62101LY EUDAMED
- EMDN Code
- Q01010101 AMALGAMS FOR RESTORATIVE DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Hollenback Amalgam Instruments by Immane Corporation — 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 | ++G375IMC62101LY | Class I | Active |
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Manufacturer
- Manufacturer
- Immane Corporation
- EUDAMED SRN
- PK-MF-000035233
- Authorised Representative
- CS Active LV-AR-000011602
Sources (1)
- EUDAMED 91484d91-acb8-41be-a131-3cb8de329e1a 61 fields · synced Jul 19, 2026