Identity
- Trade Name
- BISS Hammer EUDAMEDBISS FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Device Name
- BISS Hammer EUDAMEDFDA UDI
- Model / Reference
- BISS_HAM EUDAMEDFDA UDI
- Description
- BISS hammer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260468254537 EUDAMEDFDA UDI
- Basic UDI-DI
- 426046825TD03PG09CX EUDAMED
- Direct Marketing DI
- 04260468254537 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical mallet FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
No
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
BISS Hammer by SDS Swiss Dental Solutions AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426046825TD03PG09CX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SDS Swiss Dental Solutions AG
- EUDAMED SRN
- CH-MF-000019073
- Authorised Representative
- SDS Deutschland GmbH DE-AR-000005774
Sources (2)
- EUDAMED 95faf60f-f5b6-48d8-bf49-cbaf19ed3dc4 61 fields · synced Jul 9, 2026
- FDA UDI cf848bdd-1efe-4b30-a533-54d9f63219ef 34 fields · synced May 30, 2026