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Sharp pin
EUDAMEDClass IIa (EU MDR)
Ref 400425-011Ref 400425-004Ref 400425-001Ref 400425-007Ref 400425-009
Identity
- Device Name
- Sharp pin EUDAMED
- Model / Reference
- 400425-011 EUDAMED400425-004 EUDAMED400425-001 EUDAMED400425-007 EUDAMED400425-009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810055523139 EUDAMED00810055522903 EUDAMED00810055522873 EUDAMED00810055523092 EUDAMED00810055523115 EUDAMED
- Basic UDI-DI
- 081005552SharpPin3P EUDAMED
- Direct Marketing DI
- 00810055523139 EUDAMED00810055522903 EUDAMED00810055522873 EUDAMED00810055523092 EUDAMED00810055523115 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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: Joint prosthesis implantation kit, single-use
Sharp pin by Si-Bone Inc. — 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 | 081005552SharpPin3P | Class IIa | Active |
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Manufacturer
- Manufacturer
- SI-BONE, Inc.
- EUDAMED SRN
- US-MF-000028624
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (5)
- EUDAMED f0f9500a-fc8e-4a65-bd83-ac72828a5d10 61 fields · synced Aug 2, 2026
- EUDAMED 40650af5-5ba3-4480-b737-aea742a26b8a 61 fields · synced May 16, 2026
- EUDAMED 3e4c6508-8ea5-4557-ad78-5470030c3edb 61 fields · synced May 17, 2026
- EUDAMED a902b6c0-3acc-47b0-af51-895278bb0d80 61 fields · synced May 17, 2026
- EUDAMED 9d2086b9-861a-4dba-aae3-caace405adb0 61 fields · synced May 18, 2026