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Medpoint
EUDAMEDClass IIa (EU MDR)
Ref 10-0120 Standard CS No.20Ref 10-0211 Standard CS No.11Ref 10-0121 Standard CS No.21Ref 10-0124 Standard CS No.24Ref 10-0122 Standard CS No.22Ref 10-0112 Standard CS No.12Ref 10-0115C Standard CS No.15CRef 10-0118 Standard CS No.18Ref 10-0123 Standard CS No.23
Identity
- Trade Name
- Medpoint EUDAMED
- Device Name
- Disposable Surgical Blades EUDAMED
- Model / Reference
- 10-0120 Standard CS No.20 EUDAMED10-0211 Standard CS No.11 EUDAMED10-0121 Standard CS No.21 EUDAMED10-0124 Standard CS No.24 EUDAMED10-0122 Standard CS No.22 EUDAMED10-0112 Standard CS No.12 EUDAMED10-0115C Standard CS No.15C EUDAMED10-0118 Standard CS No.18 EUDAMED10-0123 Standard CS No.23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630124348 EUDAMED16945630124300 EUDAMED16945630124355 EUDAMED16945630124386 EUDAMED16945630124362 EUDAMED16945630124317 EUDAMED16945630124324 EUDAMED16945630124331 EUDAMED16945630124379 EUDAMED
- Basic UDI-DI
- 6945630110BA EUDAMED
- Unit of Use DI
- 06945630124341 EUDAMED06945630124303 EUDAMED06945630124358 EUDAMED06945630124389 EUDAMED06945630124365 EUDAMED06945630124310 EUDAMED06945630124327 EUDAMED06945630124334 EUDAMED06945630124372 EUDAMED
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES 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
Medpoint 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 |
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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 (9)
- EUDAMED 438fc8d9-3f1d-4dd5-bf42-94e6a291e48c 61 fields · synced Sep 18, 2026
- EUDAMED e24df1b7-b381-4724-ae1e-0fb99d668871 61 fields · synced May 17, 2026
- EUDAMED 28ca5969-b4b9-428c-b285-54c0dedb5311 61 fields · synced May 17, 2026
- EUDAMED 12712ebe-e5d0-480a-ba13-d541d8ed6499 61 fields · synced May 17, 2026
- EUDAMED 4bbf5003-c3a7-4bb8-b3a2-335432b2daa8 61 fields · synced May 17, 2026
- EUDAMED 337379da-c20e-4bec-8c26-12ff7a15ec60 61 fields · synced May 17, 2026
- EUDAMED 9eefcd64-f566-4fc5-870b-40ecd3776f77 61 fields · synced May 18, 2026
- EUDAMED 50820956-a38d-4026-a744-c8cc1a452180 61 fields · synced May 18, 2026
- EUDAMED 4e74d081-6d1e-4d31-aba8-8362d9dc98a6 61 fields · synced May 19, 2026