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[Pearce] Nucleus Spatula, angled
EUDAMEDClass IIa (EU MDR)
Ref 8208Model Manual Handled Instruments
Identity
- Trade Name
- [Pearce] Nucleus Spatula, angled EUDAMED
- Model / Reference
- Manual Handled Instruments EUDAMED8208 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516107097 EUDAMED
- Basic UDI-DI
- 08405161820063 EUDAMED
- EMDN Code
- Q021109 OPHTHALMIC SURGERY SPATULAS, 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
[Pearce] Nucleus Spatula, angled 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 | 08405161820063 | 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 f826d810-658e-45f8-80f7-5af6292c01e3 61 fields · synced Jul 19, 2026