Identity
- Trade Name
- Micro-Sickel Knife FDA UDI
- Generic Name
- Ear knife FDA UDI
- Device Name
- Micro-Sickel Knife 31-5143 EUDAMED
- Model / Reference
- 31-5143 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00883475951189 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00883475951189 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
Micro-Sickel Knife 31-5143 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-00883475951189 | 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 2e6a5c37-78c6-47e1-ace4-ae7ff52f76bb 61 fields · synced Jun 19, 2026
- FDA UDI d8124f0a-0a94-438b-91bd-387b86daef76 32 fields · synced May 30, 2026