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Hollenback Amalgam Instruments

EUDAMED

Class I (EU MDR)

Ref IMC­62­101Model IMC­62­101 to IMC­62­123

by Immane Corporation

Identity

Trade Name
Hollenback Amalgam Instruments EUDAMED
Device Name
Amalgam Instruments EUDAMED
Model / Reference
IMC­62­101 to IMC­62­123 EUDAMED
IMC­62­101 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

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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