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“X” Osteotome, 7mm
EUDAMEDClass I (EU MDR)
Ref 11-027-000Ref 11-021-000Ref 11-030-000Ref 11-031-000Ref 11-022-000
Identity
- Device Name
- “X” Osteotome, 7mm EUDAMED
- Model / Reference
- 11-027-000 EUDAMED11-021-000 EUDAMED11-030-000 EUDAMED11-031-000 EUDAMED11-022-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847538002041 EUDAMED00847538001778 EUDAMED00847538002072 EUDAMED00847538002089 EUDAMED00847538001785 EUDAMED
- Basic UDI-DI
- 08475380128442U EUDAMED
- Direct Marketing DI
- 00847538002041 EUDAMED00847538001778 EUDAMED00847538002072 EUDAMED00847538002089 EUDAMED00847538001785 EUDAMED
- EMDN Code
- L090404 OSTEOTOMES AND SCALPELS BLADES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
“X” Osteotome, 7mm by Symmetry Medical Manufacturing, Inc. — Class I — 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 | 08475380128442U | Class I | Active |
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Manufacturer
- Manufacturer
- Symmetry Medical Manufacturing, Inc.
- EUDAMED SRN
- US-MF-000025394
- Authorised Representative
- SYMMETRY MEDICAL POLYVAC FR-AR-000003187
Sources (5)
- EUDAMED 05e04a23-1e2d-4abc-8ef2-bd3076a51042 61 fields · synced Oct 6, 2026
- EUDAMED 39d70e96-e144-4c1f-86c7-df2e924c0c30 61 fields · synced May 16, 2026
- EUDAMED 96055ab9-aabc-43ec-b9fe-16c266cfe624 61 fields · synced May 18, 2026
- EUDAMED 10d71ef9-64bf-447f-b3d9-a5984fbe5c02 61 fields · synced May 18, 2026
- EUDAMED b691d7be-3b50-40d4-a65d-25973798106b 61 fields · synced May 18, 2026