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Cys

EUDAMED

Class 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

by Changzhou Medical Bioengineering Co., Ltd.

Identity

Trade Name
CYS EUDAMED
Device Name
Disposable Skin Stapler EUDAMED
Circumcision Staplers For Single Use EUDAMED
Disposable Infusion Pump EUDAMED
Model / Reference
CSPF-15W CSPF-25W CSPF-35W CSPF-15R CSPF-25R CSPF-35R etc EUDAMED
PF0035R/CSPF-35R EUDAMED
PF00CW/CSPF-CW EUDAMED
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 etc EUDAMED
FA0025B/CSFA-B25 EUDAMED
FA0013C/CSFA-C13 EUDAMED
FA0029B/CSFA-B29 EUDAMED
PF0025W/CSPF-25W EUDAMED
FA0022C/CSFA-C22 EUDAMED
FA0013B/CSFA-B13 EUDAMED
FA0011A/CSFA-A11 EUDAMED
FA0029A/CSFA-A29 EUDAMED
FA0022B/CSFA-B22 EUDAMED
FA0034A/CSFA-A34 EUDAMED
FA0032A/CSFA-A32 EUDAMED
FA0017A/CSFA-A17 EUDAMED
FA0034B/CSFA-B34 EUDAMED
FA0025A/CSFA-A25 EUDAMED
FA0034C/CSFA-C34 EUDAMED
PF0035K/CSPF-35K EUDAMED
PF0015Z/CSPF-15Z EUDAMED
PF0015R/CSPF-15R EUDAMED
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 etc EUDAMED
F0040M /CBI-M100 4.0mL/h EUDAMED
FA0013A/CSFA-A13 EUDAMED
PF0025Z/CSPF-25Z EUDAMED
CSFA-A13 EUDAMED

Identifiers

Primary DI / UDI-DI
06956862070078 EUDAMED
06956862080015 EUDAMED
06956862016106 EUDAMED
06956862016137 EUDAMED
06956862016113 EUDAMED
06956862070023 EUDAMED
06956862016151 EUDAMED
06956862016076 EUDAMED
06956862016212 EUDAMED
06956862016052 EUDAMED
06956862016090 EUDAMED
06956862016069 EUDAMED
06956862016205 EUDAMED
06956862016021 EUDAMED
06956862016120 EUDAMED
06956862016045 EUDAMED
06956862016182 EUDAMED
06956862070115 EUDAMED
06956862070139 EUDAMED
06956862070054 EUDAMED
06956862090151 EUDAMED
06956862016014 EUDAMED
06956862070146 EUDAMED
Basic UDI-DI
69568620PFJN EUDAMED
69568620BPHY EUDAMED
69568620CBI5Q EUDAMED
B-06956862016014 EUDAMED
EMDN Code
H02010101 SKIN STAPLERS, SINGLE-USE EUDAMED
A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
H02010199 MECHANICAL SKIN STAPLERS - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Spain EUDAMED
Türkiye EUDAMED
Italy EUDAMED
Greece 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

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Manufacturer

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