Identity
- Trade Name
- Surgical Loupe EUDAMED
- Device Name
- Surgical Loupe EUDAMED
- Model / Reference
- TTL Loupe EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809891830831 EUDAMED
- Basic UDI-DI
- 8809891830831G9 EUDAMED
- EMDN Code
- L0316 HELMETS AND BINOCULAR GLASSES FOR SURGEONS 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
Category: Surgical binoculars, reusable
Surgical Loupe by Minam Optics Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical binoculars, reusable.
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- Surgical Telescope — Xenosys Co., Ltd. · Class I
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 | 8809891830831G9 | Class I | Active |
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Manufacturer
- Manufacturer
- Minam Optics Co., Ltd
- EUDAMED SRN
- KR-MF-000042784
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED d484d00d-558b-4eaf-be65-2e1f6a607867 61 fields · synced Jun 18, 2026