Identity
- Trade Name
- Blade Handle(K) FDA UDI
- Generic Name
- Dura mater knife FDA UDI
- Device Name
- Blade Handle (K) 31-1001 EUDAMED
- Model / Reference
- 31-1001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00883475950946 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00883475950946 EUDAMED
- FDA Product Code
- EMF FDA UDI
- EMDN Code
- L0102 SURGICAL KNIVES, REUSABLE EUDAMED
- GMDN Term
- Dura mater knife 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
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
Blade Handle (K) 31-1001 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-00883475950946 | 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 9b918b62-41b6-444f-8a3f-42ab7c74aa3c 61 fields · synced Jun 17, 2026
- FDA UDI 107b525e-fadd-4818-b2cf-594d64c9a8d3 32 fields · synced May 29, 2026