Endo-Chisel, without Handle
EUDAMEDFDA UDIClass I (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- Endo-Chisel, without Handle EUDAMEDchisel FDA UDI
- Generic Name
- Orthopaedic chisel FDA UDI
- Device Name
- Endo-Chisel, without Handle EUDAMEDFDA UDIEndo-Chisel EUDAMED
- Model / Reference
- TEC372620 EUDAMEDFDA UDI
- Description
- Endo-Chisel, without Handle FDA UDI
Identifiers
- Catalog Number
- TEC372620 FDA UDI
- Primary DI / UDI-DI
- 04250337101147 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337101147 EUDAMED42503371ABLACHI4Q EUDAMED
- FDA Product Code
- FZS FDA UDI
- EMDN Code
- L1102 NEUROSURGERY SPATULAS AND DISSECTORS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic chisel 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
Endo-Chisel, without Handle 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
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337101147 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337101147 | 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 207ec218-8f1a-4709-b5a8-81f8bd10c60f 61 fields · synced Jul 30, 2026
- EUDAMED 2d73f16a-5597-4b97-8705-75ab64b5563f 61 fields · synced May 19, 2026
- FDA UDI 19870d8b-470b-4cf4-82f1-da43a7840333 36 fields · synced May 30, 2026