Identity
- Device Name
- EXOPHTHALMOMETER EUDAMED
- Model / Reference
- K-0161 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547451023609 EUDAMED
- Basic UDI-DI
- 454745100007AC EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Exophthalmometer by Inami & Co., Ltd. — 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 | 454745100007AC | Class I | Active |
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Manufacturer
- Manufacturer
- Inami & Co., Ltd.
- EUDAMED SRN
- JP-MF-000040062
- Authorised Representative
- WMDE B.V. NL-AR-000002062
Sources (1)
- EUDAMED f84dc3c2-a1e9-48dd-abb2-2dec72d585a3 61 fields · synced Jul 15, 2026