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X-Cut
EUDAMEDClass IIa (EU MDR)
Ref CS 23#Ref CS 22#Ref CS 18#Ref CS 24#Ref CS 21#Ref CS 20#Ref CS 11#
Identity
- Trade Name
- X-CUT EUDAMED
- Device Name
- Disposable Surgical Blades EUDAMED
- Model / Reference
- CS 23# EUDAMEDCS 22# EUDAMEDCS 18# EUDAMEDCS 24# EUDAMEDCS 21# EUDAMEDCS 20# EUDAMEDCS 11# EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630139908 EUDAMED16945630139892 EUDAMED16945630139861 EUDAMED16945630139915 EUDAMED16945630139885 EUDAMED16945630139878 EUDAMED16945630139830 EUDAMED
- Basic UDI-DI
- 6945630110BA EUDAMED
- Unit of Use DI
- 06945630139901 EUDAMED06945630139895 EUDAMED06945630139864 EUDAMED06945630139918 EUDAMED06945630139888 EUDAMED06945630139871 EUDAMED06945630139833 EUDAMED
- EMDN Code
- V010102 SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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: Scalpel, single-use
X-Cut by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel, single-use.
- MANI ENT Knife — MANI, INC. · Class I
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Bard-Parker ® Disposable Scalpels — Aspen Surgical Products, Inc. · Class I
- Sharpoint — Surgical Specialties México, S. de R.L. de C.V. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Stylus — Surgical Specialties México, S. de R.L. de C.V. · 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 (7)
- EUDAMED 41fde197-5eb4-40ee-96cd-dbb675a54f2a 61 fields · synced Jul 30, 2026
- EUDAMED d87f9963-efab-4c76-a0ac-00badaa5ac32 61 fields · synced May 16, 2026
- EUDAMED a9708845-717c-49fb-ae42-d83e590ce6ae 61 fields · synced May 16, 2026
- EUDAMED e398d71b-9974-4fdb-9871-90d41d4088ac 61 fields · synced May 16, 2026
- EUDAMED 8ceb47a5-41d2-471f-be46-6cccb7ce13b0 61 fields · synced May 18, 2026
- EUDAMED c5d51cc9-d01b-4a47-a094-76f1a791042c 61 fields · synced May 18, 2026
- EUDAMED fe1da9eb-3eb0-4f6b-afdd-c53d7988a1eb 61 fields · synced May 19, 2026