Identity
- Trade Name
- Curette EUDAMEDFDA UDI
- Generic Name
- Bone curette, reusable FDA UDI
- Device Name
- Curette EUDAMEDFDA UDI
- Model / Reference
- DEC293511 EUDAMEDFDA UDI
- Description
- Curette FDA UDI
Identifiers
- Catalog Number
- DEC293511 FDA UDI
- Primary DI / UDI-DI
- 04250337115380 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337115380 EUDAMED42503371ABLACUR6H 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
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
Category: Surgical retractor/retraction system blade, reusable
Curette by Joimax GmbH — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-04250337115380 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337115380 | 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 8aff908f-1330-4167-a460-7d2b5ee5d3b2 61 fields · synced Jul 22, 2026
- EUDAMED 4639bcfa-c6f3-47b4-9488-ee92ef547cc1 61 fields · synced May 18, 2026
- FDA UDI 76a893ec-3a20-4daf-a7b9-9f770275df76 36 fields · synced May 30, 2026