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First Blades
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Standard CS 22#Ref 10-0115 Standard CS No.15Ref 10-0121 Standard CS No.21Ref 10-0111 Standard CS No.11Ref 10-0123 Standard CS No.23
Identity
- Trade Name
- FIRST BLADES EUDAMEDFIRST BLADES DISPOSABLE SURGICAL BLADES FDA UDI
- Generic Name
- Manual scalpel blade, single-use FDA UDI
- Device Name
- Disposable Surgical Blades EUDAMED
- Model / Reference
- Standard CS 22# EUDAMEDFDA UDI10-0115 Standard CS No.15 EUDAMED10-0121 Standard CS No.21 EUDAMED10-0111 Standard CS No.11 EUDAMED10-0123 Standard CS No.23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630133470 EUDAMEDFDA UDI16945630124287 EUDAMED16945630124232 EUDAMED16945630124195 EUDAMED16945630124256 EUDAMED16945630124218 EUDAMED
- Basic UDI-DI
- 6945630110BA EUDAMED
- Unit of Use DI
- 06945630133473 EUDAMED06945630124280 EUDAMED06945630124235 EUDAMED06945630124198 EUDAMED06945630124259 EUDAMED06945630124211 EUDAMED
- FDA Product Code
- GES FDA UDI
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Manual scalpel blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Category: Manual scalpel blade, single-use
First Blades by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual scalpel blade, single-use.
- Paramount — Paramount Surgimed Limited · Class IIa
- Bard-Parker ® Carbon Rib-Back Blades — Aspen Surgical Products, Inc. · Class I
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · Class I
- Sterile Stainless Blades — Southmedic Incorporated · Class I
- Paramount — Paramount Surgimed Limited · Class IIa
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · Class I
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 | 6945630110BA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (7)
- EUDAMED 05265655-e4f2-4b50-aa25-5aa5ec13411b 61 fields · synced Aug 1, 2026
- EUDAMED 6c2e3410-dec5-43f0-803f-769fa45560da 61 fields · synced May 16, 2026
- EUDAMED 90866462-b5d8-41c2-afbe-ce0ce8b9b04f 61 fields · synced May 17, 2026
- EUDAMED 346760ce-2575-4782-bdd1-1a6c167c05dc 61 fields · synced May 17, 2026
- EUDAMED 14b8f175-f086-4f23-b502-14fde1b85d7f 61 fields · synced May 18, 2026
- EUDAMED 6b1091d9-7421-4918-854a-45d9298596fb 61 fields · synced May 19, 2026
- FDA UDI 6e76257b-b4ba-46c8-be5c-398fe0d99039 32 fields · synced May 30, 2026