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Instruments box
EUDAMEDClass I (EU MDR)
Ref IMC80121Model IMC80121 to IMC80165
Identity
- Trade Name
- Instruments box EUDAMED
- Device Name
- Hollow wares EUDAMED
- Model / Reference
- IMC80121 to IMC80165 EUDAMEDIMC80121 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G375IMC8012107 EUDAMED
- Basic UDI-DI
- ++G375IMC80101M8 EUDAMED
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS 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
Instruments box 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 | ++G375IMC80101M8 | 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 989e001b-0751-4578-9fd1-83538fef0d71 61 fields · synced Jun 20, 2026