Identity
- Trade Name
- Dissector EUDAMEDFDA UDI
- Generic Name
- Bone curette, reusable FDA UDI
- Device Name
- Curette EUDAMEDDissector EUDAMEDFDA UDI
- Model / Reference
- JDA363515 EUDAMEDFDA UDI
- Description
- Dissector FDA UDI
Identifiers
- Catalog Number
- JDA363515 FDA UDI
- Primary DI / UDI-DI
- 04250337115816 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371ABLACUR6H EUDAMEDB-04250337115816 EUDAMED
- FDA Product Code
- FZS FDA UDI
- EMDN Code
- L1102 NEUROSURGERY SPATULAS AND DISSECTORS, REUSABLE EUDAMED
- GMDN Term
- Bone curette, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical retractor/retraction system blade, reusable
Dissector by Joimax GmbH — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 42503371ABLACUR6H | Class I | Active |
| EUDAMED | European Union | CE/MDR | 42503371ABLACUR6H | 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 b2f31c74-b93b-4d21-bb3c-60c3d424ba65 61 fields · synced Jul 19, 2026
- EUDAMED c2f32e2b-6dc7-4e61-82e2-f820d7f060b2 61 fields · synced May 19, 2026
- FDA UDI 042dddaf-6329-4803-87d3-eb97ad884b98 36 fields · synced May 30, 2026