Identity
- Trade Name
- SURGISTAR FDA UDI
- Generic Name
- Scalpel, single-use FDA UDI
- Model / Reference
- Myringotomy/Tympanoplasty EUDAMED8125 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00878799002761 EUDAMEDFDA UDI
- Basic UDI-DI
- 087879900ENTST EUDAMED
- FDA Product Code
- EMF FDA UDI
- EMDN Code
- Q030301 ENT SURGERY BLADES, SINGLE-USE EUDAMED
- GMDN Term
- Scalpel, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
8125 by Surgistar Inc. — Class IIa — 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 | 087879900ENTST | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Surgistar Inc.
- EUDAMED SRN
- US-MF-000003747
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 67a0a4e0-a604-4efc-a92c-66563216b125 61 fields · synced Jul 16, 2026
- FDA UDI 83cd97d2-bf10-419c-98c3-edaee26bd70c 33 fields · synced May 30, 2026