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[Barraquer] Eye Speculum, adult
EUDAMEDClass IIa (EU MDR)
Ref 8400Model Speculum
Identity
- Trade Name
- [Barraquer] Eye Speculum, adult EUDAMED
- Model / Reference
- Speculum EUDAMED8400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516126708 EUDAMED00840516129211 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
EUDAMEDEUDAMED
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
[Barraquer] Eye Speculum, adult 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 (2)
- EUDAMED f0c22bbb-8243-4ccf-9449-f6761b15eb59 61 fields · synced Jul 25, 2026
- EUDAMED c9a3fdc6-c968-49b3-959b-b3e0cd40e590 61 fields · synced Jul 25, 2026