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Knife for Tumor Standard 45deg. 31-5133
EUDAMEDFDA UDIClass I (EU MDR)
Ref 31-5133
Identity
- Trade Name
- Knife for Tumor Standard 45deg. FDA UDI
- Generic Name
- Ear knife FDA UDI
- Device Name
- Knife for Tumor Standard 45deg. 31-5133 EUDAMED
- Model / Reference
- 31-5133 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00883475950212 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00883475950212 EUDAMED
- FDA Product Code
- KTG FDA UDI
- EMDN Code
- L0102 SURGICAL KNIVES, REUSABLE EUDAMED
- GMDN Term
- Ear knife FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Knife for Tumor Standard 45deg. 31-5133 by Charmant Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00883475950212 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Charmant Inc.
- EUDAMED SRN
- JP-MF-000023565
- Authorised Representative
- Charmant GmbH Europe DE-AR-000022071
Sources (2)
- EUDAMED dcf7d4ea-18c6-49d9-af73-5dd4958781a8 61 fields · synced Aug 2, 2026
- FDA UDI 212106f1-3a0e-41a3-aac8-1914841c9b41 32 fields · synced May 30, 2026