← Back to catalogue
Cys
EUDAMEDClass IIa (EU MDR)
Ref PF0035R/CSPF-35RModel CSPF-15W CSPF-25W CSPF-35W CSPF-15R CSPF-25R CSPF-35R etcRef PF00CW/CSPF-CWRef FA0025B/CSFA-B25Model CSFA-A11 CSFA-A13 CSFA-A15 CSFA-A17 CSFA-A22 CSFA-A25 CSFA-A29 CSFA-A32 CSFA-A34 CSFA-B13 CSFA-B17 CSFA-B22 CSFA-B25 etcRef FA0013C/CSFA-C13Ref FA0029B/CSFA-B29Ref PF0025W/CSPF-25WRef FA0022C/CSFA-C22Ref FA0013B/CSFA-B13Ref FA0011A/CSFA-A11Ref FA0029A/CSFA-A29Ref FA0022B/CSFA-B22Ref FA0034A/CSFA-A34Ref FA0032A/CSFA-A32Ref FA0017A/CSFA-A17Ref FA0034B/CSFA-B34Ref FA0025A/CSFA-A25Ref FA0034C/CSFA-C34Ref PF0035K/CSPF-35KRef PF0015Z/CSPF-15ZRef PF0015R/CSPF-15RRef F0040M /CBI-M100 4.0mL/hModel CBI-M60 2.0mL/h CBI-M60 5.0mL/h CBI-M60 10.0mL/h CBI-M100 2.0mL/h CBI-M100 3.0mL/h CBI-M100 4.0mL/h CBI-M100 5.0mL/h CBI-M100 8.0mL/h CBI-M100 13.0mL/h etcRef FA0013A/CSFA-A13Ref PF0025Z/CSPF-25ZModel CSFA-A13
Identity
- Trade Name
- CYS EUDAMED
- Device Name
- Disposable Skin Stapler EUDAMEDCircumcision Staplers For Single Use EUDAMEDDisposable Infusion Pump EUDAMED
- Model / Reference
- CSPF-15W CSPF-25W CSPF-35W CSPF-15R CSPF-25R CSPF-35R etc EUDAMEDPF0035R/CSPF-35R EUDAMEDPF00CW/CSPF-CW EUDAMEDCSFA-A11 CSFA-A13 CSFA-A15 CSFA-A17 CSFA-A22 CSFA-A25 CSFA-A29 CSFA-A32 CSFA-A34 CSFA-B13 CSFA-B17 CSFA-B22 CSFA-B25 etc EUDAMEDFA0025B/CSFA-B25 EUDAMEDFA0013C/CSFA-C13 EUDAMEDFA0029B/CSFA-B29 EUDAMEDPF0025W/CSPF-25W EUDAMEDFA0022C/CSFA-C22 EUDAMEDFA0013B/CSFA-B13 EUDAMEDFA0011A/CSFA-A11 EUDAMEDFA0029A/CSFA-A29 EUDAMEDFA0022B/CSFA-B22 EUDAMEDFA0034A/CSFA-A34 EUDAMEDFA0032A/CSFA-A32 EUDAMEDFA0017A/CSFA-A17 EUDAMEDFA0034B/CSFA-B34 EUDAMEDFA0025A/CSFA-A25 EUDAMEDFA0034C/CSFA-C34 EUDAMEDPF0035K/CSPF-35K EUDAMEDPF0015Z/CSPF-15Z EUDAMEDPF0015R/CSPF-15R EUDAMEDCBI-M60 2.0mL/h CBI-M60 5.0mL/h CBI-M60 10.0mL/h CBI-M100 2.0mL/h CBI-M100 3.0mL/h CBI-M100 4.0mL/h CBI-M100 5.0mL/h CBI-M100 8.0mL/h CBI-M100 13.0mL/h etc EUDAMEDF0040M /CBI-M100 4.0mL/h EUDAMEDFA0013A/CSFA-A13 EUDAMEDPF0025Z/CSPF-25Z EUDAMEDCSFA-A13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956862070078 EUDAMED06956862080015 EUDAMED06956862016106 EUDAMED06956862016137 EUDAMED06956862016113 EUDAMED06956862070023 EUDAMED06956862016151 EUDAMED06956862016076 EUDAMED06956862016212 EUDAMED06956862016052 EUDAMED06956862016090 EUDAMED06956862016069 EUDAMED06956862016205 EUDAMED06956862016021 EUDAMED06956862016120 EUDAMED06956862016045 EUDAMED06956862016182 EUDAMED06956862070115 EUDAMED06956862070139 EUDAMED06956862070054 EUDAMED06956862090151 EUDAMED06956862016014 EUDAMED06956862070146 EUDAMED
- Basic UDI-DI
- 69568620PFJN EUDAMED69568620BPHY EUDAMED69568620CBI5Q EUDAMEDB-06956862016014 EUDAMED
- EMDN Code
- H02010101 SKIN STAPLERS, SINGLE-USE EUDAMEDA05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMEDH02010199 MECHANICAL SKIN STAPLERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDTürkiye EUDAMEDItaly EUDAMEDGreece 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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cys by Changzhou Medical Bioengineering Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69568620PFJN | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69568620PFJN | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Changzhou Medical Bioengineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000026604
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (24)
- EUDAMED a15a386a-785f-4de7-a115-5a22cfdbe164 61 fields · synced Sep 17, 2026
- EUDAMED ad63ba7b-e9b4-4abd-88bd-24fce4c85fb7 61 fields · synced May 11, 2026
- EUDAMED 96a09d97-cc8b-4e7a-b511-213e91d95a7c 61 fields · synced May 16, 2026
- EUDAMED dbcf67ba-f9b4-41d0-b76e-06acb8f5a208 61 fields · synced May 16, 2026
- EUDAMED fcc78f43-775e-403f-8a8e-346628f4d897 61 fields · synced May 16, 2026
- EUDAMED c27186ea-4b37-47ec-85a3-8812a388f410 61 fields · synced May 16, 2026
- EUDAMED 7183918a-8de0-41a2-aaab-5fba730f3592 61 fields · synced May 17, 2026
- EUDAMED fe1dfd1a-8854-4612-ad73-f25b889abeea 61 fields · synced May 17, 2026
- EUDAMED 856517ba-97f3-4b40-8a1f-fd23b5cfcd70 61 fields · synced May 17, 2026
- EUDAMED 38b9f283-6726-41ad-b3e0-874b662fd0b4 61 fields · synced May 17, 2026
- EUDAMED dcf79493-33f3-43c8-a3a0-e9458283d8ab 61 fields · synced May 17, 2026
- EUDAMED 267715eb-498b-4d8e-a13a-84ab0dede462 61 fields · synced May 17, 2026
- EUDAMED 69c99da2-8fbd-4f00-8361-e462ab613abb 61 fields · synced May 17, 2026
- EUDAMED b260255e-b37c-4f34-97ab-f839c7508dfb 61 fields · synced May 17, 2026
- EUDAMED b336b6f6-39aa-48f9-9465-3bd8bc6675b7 61 fields · synced May 18, 2026
- EUDAMED a0842166-7c1e-4cdd-b7e1-bdc6869caab2 61 fields · synced May 18, 2026
- EUDAMED 0caadfd9-52a4-4002-8c78-dcdc6ffa4d00 61 fields · synced May 18, 2026
- EUDAMED 7728daca-d041-4873-adc0-2e617106c283 61 fields · synced May 18, 2026
- EUDAMED 767d9fc0-dea1-4782-b2fa-04ff388b545e 61 fields · synced May 18, 2026
- EUDAMED a7013184-2fbd-4687-a8b7-f5a3f377998e 61 fields · synced May 18, 2026
- EUDAMED 83a91de0-feae-4c03-b25f-8aae2d429833 61 fields · synced May 18, 2026
- EUDAMED 211b6927-7803-41cd-b365-ded21445f724 61 fields · synced May 19, 2026
- EUDAMED 613fec43-994b-4f96-bb7f-42b2b5961547 61 fields · synced May 19, 2026
- EUDAMED c81e38ee-fae9-4e12-8549-61f44f9b86f8 61 fields · synced Aug 1, 2026