Identity
- Trade Name
- MicroCult EUDAMED
- Device Name
- Disposable Surgical Blades EUDAMEDDisposable Steel Lancets EUDAMED
- Model / Reference
- 10-0122 EUDAMED片式针Steel型 EUDAMED10-0124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630140959 EUDAMED16945630140980 EUDAMED16945630140966 EUDAMED
- Basic UDI-DI
- 6945630110BA EUDAMED6945630150BN EUDAMED
- Unit of Use DI
- 06945630140952 EUDAMED06945630140983 EUDAMED06945630140969 EUDAMED
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMEDV010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Manual scalpel blade, single-use
MicroCult by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR — listed in EUDAMED — 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 (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6945630110BA | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED b7248489-897c-4ac0-9139-86de1a8ac34d 61 fields · synced Jul 31, 2026
- EUDAMED 9627be7d-ebe1-4673-9988-c11914c75d6f 61 fields · synced May 17, 2026
- EUDAMED 7ff6b3f2-3a97-4130-94f3-8460827f1c54 61 fields · synced May 18, 2026