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joimax® Bone Drill 6.5 mm, cannulated, unsterile
EUDAMEDFDA UDIClass I (EU MDR)
Ref DCC246521
by Joimax GmbH
Identity
- Trade Name
- joimax® Bone Drill 6.5 mm, cannulated, unsterile EUDAMEDBone drill FDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- joimax® Bone Drill 6.5 mm, cannulated, unsterile EUDAMEDFDA UDIBone Drill EUDAMED
- Model / Reference
- DCC246521 EUDAMEDFDA UDI
- Description
- joimax® Bone Drill 6.5 mm, cannulated, unsterile FDA UDI
Identifiers
- Catalog Number
- DCC246521 FDA UDI
- Primary DI / UDI-DI
- 04250337105954 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337105954 EUDAMED42503371REAMDRIEW EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L1113 NEUROSURGERY BURS AND TIPS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
joimax® Bone Drill 6.5 mm, cannulated, unsterile by Joimax GmbH — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337105954 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337105954 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED 7ef95f6b-8ce0-4d4d-9c44-5571b28e8fab 61 fields · synced Jul 21, 2026
- EUDAMED ea654b65-2206-4943-be38-642bb357e269 61 fields · synced May 19, 2026
- FDA UDI ec811364-5a22-42df-821d-1d6ed7b7b7d2 36 fields · synced May 30, 2026