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JMS Infusion Set
EUDAMEDClass IIa (EU MDR)
Ref 801-5025Ref 801-5035Ref 801-6153
Identity
- Trade Name
- JMS Infusion Set EUDAMED
- Device Name
- Infusion Set EUDAMED
- Model / Reference
- 801-5025 EUDAMED801-5035 EUDAMED801-6153 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 58888483000680 EUDAMED58888483000710 EUDAMED58888483000734 EUDAMED
- Basic UDI-DI
- B-58888483000680 EUDAMEDB-58888483000710 EUDAMEDB-58888483000734 EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
JMS Infusion Set by Jms Singapore Pte Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-58888483000680 | Class IIa | Active |
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Manufacturer
- Manufacturer
- JMS Singapore Pte Ltd
- EUDAMED SRN
- SG-MF-000024704
- Authorised Representative
- Bionic Medizintechnik GmbH DE-AR-000012049
Sources (3)
- EUDAMED 653ac8b5-4995-4a60-8417-cc311ed9c86a 61 fields · synced Oct 6, 2026
- EUDAMED bdd04935-16ef-48e7-bb40-98b2269626a1 61 fields · synced May 18, 2026
- EUDAMED 0926ee10-5468-4ce6-861a-47750f2f314c 61 fields · synced May 19, 2026