Identity
- Trade Name
- Maloney PRK spatula EUDAMED
- Device Name
- Ophthalmic Spatula EUDAMED
- Model / Reference
- D30-1100-3000 EUDAMEDD30-2540 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G006D30254004 EUDAMED
- Basic UDI-DI
- ++G006OphthalmicSpatulaFH EUDAMED
- EMDN Code
- L1706 OPHTHALMOLOGY SPATULAS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Ocular hook/spatula/manipulator, reusable
Maloney PRK spatula by Daud Jee Mfg. Co — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ocular hook/spatula/manipulator, reusable.
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- Walcott Rx Products — Walcott Rx Product Inc · 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 | ++G006OphthalmicSpatulaFH | Class I | Active |
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Manufacturer
- Manufacturer
- Daud Jee Mfg. Co
- EUDAMED SRN
- PK-MF-000009615
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED d9ce9600-4a61-4a33-a8f4-79b16a22daef 61 fields · synced Jul 29, 2026