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Paramount
EUDAMEDClass IIa (EU MDR)
Ref P-985561Model Slit-Blades (Keratome) For Phaco-Stab Incision , Slit-Blades (Keratome) For I.O.L. Enlarsins , Crescent Blades , Lance Tip Blades , MVR Blades, Miniature Blades (SPOON & SCLERAL)
Identity
- Trade Name
- Paramount EUDAMED
- Device Name
- Ophthalmic Knives EUDAMED
- Model / Reference
- Slit-Blades (Keratome) For Phaco-Stab Incision , Slit-Blades (Keratome) For I.O.L. Enlarsins , Crescent Blades , Lance Tip Blades , MVR Blades, Miniature Blades (SPOON & SCLERAL) EUDAMEDP-985561 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903175005042 EUDAMED
- Basic UDI-DI
- 8903175PSLOPK9H EUDAMED
- EMDN Code
- Q02010102 OPHTHALMIC MICROKNIVES, ANGLED 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
Paramount by Paramount Surgimed Limited — 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 | 8903175PSLOPK9H | Class IIa | Active |
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Manufacturer
- Manufacturer
- Paramount Surgimed Limited
- EUDAMED SRN
- IN-MF-000021682
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED d6b6c4e1-1cff-4508-82b1-fca704ee3705 61 fields · synced Jun 17, 2026