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Flow Regulators
EUDAMEDClass IIa (EU MDR)
Ref 13161Model FLOW REGULATORSRef 13166Ref 13162Ref 13159Ref 13111Ref 13107Ref 13160Ref 13156Ref 13103Model Flow RegulatorsRef 13164Ref 13110Ref 13102Ref 13104Ref 13100Ref 13109Ref 13105Ref 13155
Identity
- Trade Name
- Flow Regulators EUDAMED
- Device Name
- FLOW REGULATORS EUDAMED
- Model / Reference
- FLOW REGULATORS EUDAMED13161 EUDAMED13166 EUDAMED13162 EUDAMED13159 EUDAMED13111 EUDAMED13107 EUDAMED13160 EUDAMED13156 EUDAMED13103 EUDAMED13164 EUDAMED13110 EUDAMED13102 EUDAMED13104 EUDAMED13100 EUDAMED13109 EUDAMED13105 EUDAMED13155 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095131619 EUDAMED08902095131664 EUDAMED08902095131626 EUDAMED08902095131596 EUDAMED08902095131114 EUDAMED08902095131077 EUDAMED08902095131602 EUDAMED08902095131565 EUDAMED08902095131039 EUDAMED08902095131640 EUDAMED08902095131107 EUDAMED08902095131022 EUDAMED08902095131046 EUDAMED08902095131008 EUDAMED08902095131091 EUDAMED08902095131053 EUDAMED08902095131558 EUDAMED
- Basic UDI-DI
- 890209513101DS EUDAMED890209513103DW EUDAMED
- EMDN Code
- A030104 FLOW REGULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDItaly EUDAMEDRomania EUDAMEDSpain EUDAMEDLithuania 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
Yes
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Flow Regulators by Poly Medicure Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 890209513101DS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043009
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (17)
- EUDAMED f0d7b32f-a660-4a29-b78c-27b359b91444 61 fields · synced Sep 17, 2026
- EUDAMED 2d344e06-2755-4992-9292-b897db5871c8 61 fields · synced May 17, 2026
- EUDAMED e6b6c584-d61f-4aa5-96d0-4d60b59302ff 61 fields · synced Jun 18, 2026
- EUDAMED 821a6657-3a62-4859-ba0b-c46e2a4255cf 61 fields · synced Jun 20, 2026
- EUDAMED ba5ea3f3-074d-48b3-a22c-c8ca5b560d18 61 fields · synced Jul 9, 2026
- EUDAMED f9b3024f-ba1e-48b4-8976-55fbfaf0781b 61 fields · synced Jul 9, 2026
- EUDAMED 862bfe92-12fe-4fc2-9e67-3778a5438425 61 fields · synced Jul 10, 2026
- EUDAMED ce2cf1c2-ce64-4a70-9b15-57a730bd4521 61 fields · synced Jul 11, 2026
- EUDAMED 093fc5e0-469a-4c50-acbb-7fb31e31e0b8 61 fields · synced Jul 11, 2026
- EUDAMED ff3607dd-ec9a-4fa6-b02d-d7c0a8c5c271 61 fields · synced Jul 14, 2026
- EUDAMED 56a9ddd8-bc82-4276-89e9-3fb0866540a4 61 fields · synced Jul 15, 2026
- EUDAMED 5617c1f8-f73d-4f42-bfd1-23d23195c85a 61 fields · synced Jul 22, 2026
- EUDAMED 2a86ea70-e140-479c-9931-2c161fcd6245 61 fields · synced Jul 23, 2026
- EUDAMED 9811b956-d396-4e9b-8ec4-dfd92590d39d 61 fields · synced Jul 25, 2026
- EUDAMED 1d5defd2-d9bc-4961-b841-9f85247104c6 61 fields · synced Jul 25, 2026
- EUDAMED 0db0ccd5-06c0-4d1d-8f0a-1dfcc315d31a 61 fields · synced Aug 2, 2026
- EUDAMED ecdb8142-6a32-469c-ae8c-36a60027cba4 61 fields · synced Aug 3, 2026