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SR Tip, Φ1.0mm, L 26mm
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref '069476003000801F4
Identity
- Trade Name
- Dental Implantation Instruments EUDAMEDSR Tip,Φ1.0mm, L 26mm FDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDI
- Device Name
- Dental Implantation Instruments EUDAMED
- Model / Reference
- '069476003000801F4 EUDAMED353150 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947600316800 EUDAMEDFDA UDI
- Basic UDI-DI
- 069476003000801F4 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, single-use 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
Yes
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
Category: Surgical screwdriver, single-use
SR Tip, Φ1.0mm, L 26mm by BIO CONCEPT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BIO CONCEPT Co., Ltd.
Sources (2)
- FDA UDI a24e090a-88fa-4a63-a974-3522862f6bfa 32 fields · synced Jun 18, 2026
- EUDAMED bc1c9600-8ed6-4ee8-ad23-5359e702f962 61 fields · synced Jun 18, 2026