Identity
- Device Name
- J-Notch Burs EUDAMED
- Model / Reference
- 08858251002041RY EUDAMED6517-048-021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613327687668 EUDAMED
- Basic UDI-DI
- 08858251002041RY EUDAMED
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
J-Notch Burs by Stryker Instruments — 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 | 08858251002041RY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Stryker Instruments
- EUDAMED SRN
- US-MF-000025219
- Authorised Representative
- Stryker European Operations Limited IE-AR-000000092
Sources (1)
- EUDAMED fbf32517-ee86-4494-942e-8b82c1c2c7a8 61 fields · synced Jul 20, 2026