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KeriKnife™ - Surgical Knife, Left Guide and Spatula
EUDAMEDClass IIa (EU MDR)
Ref 524-A91000
Identity
- Trade Name
- KeriKnife™ - Surgical Knife, Left Guide and Spatula EUDAMED
- Device Name
- KeriKnife EUDAMED
- Model / Reference
- 524-A91000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640181162307 EUDAMED
- Basic UDI-DI
- 764018116005B4 EUDAMED
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER 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: Cranial bur, single-use
KeriKnife™ - Surgical Knife, Left Guide and Spatula by Keri Medical SA — 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 | 764018116005B4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Keri Medical SA
- EUDAMED SRN
- CH-MF-000021960
- Authorised Representative
- Keri Medical France FR-AR-000009590
Sources (1)
- EUDAMED 801bb3d5-da5a-467f-ab0d-cfabdc803002 61 fields · synced Jun 20, 2026