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Eye Speculum, adult, solid blades
EUDAMEDClass IIa (EU MDR)
Ref 8403Model Speculum
Identity
- Trade Name
- Eye Speculum, adult, solid blades EUDAMED
- Model / Reference
- Speculum EUDAMED8403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516138534 EUDAMED
- Basic UDI-DI
- 0840516184006D EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Eye Speculum, adult, solid blades by Psi/Eye-Ko, Inc. — Class IIa — 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 | 0840516184006D | Class IIa | Active |
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Manufacturer
- Manufacturer
- PSI/EYE-KO, Inc.
- EUDAMED SRN
- US-MF-000022109
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 513d1f9a-29e7-4e9b-a2d1-b736687896ab 61 fields · synced Jun 20, 2026