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Peribulbar Needle [Atkinson] 25g X 32mm (1 1/4")
EUDAMEDClass IIa (EU MDR)
Ref 0003FModel Anesthesia Needles
Identity
- Trade Name
- Peribulbar Needle [Atkinson] 25g X 32mm (1 1/4") EUDAMED
- Model / Reference
- Anesthesia Needles EUDAMED0003F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516103266 EUDAMED
- Basic UDI-DI
- 0840516100003Z EUDAMED
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE 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
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Peribulbar Needle [Atkinson] 25g X 32mm (1 1/4") by Psi/Eye-Ko, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0840516100003Z | 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 a95bc74d-82ff-46f3-85ed-9d2dfa18c40f 61 fields · synced Jun 19, 2026