← Back to catalogue
Tc Additional Long Leads Kit: Iec
EUDAMEDClass I (EU MDR)
Ref 989803151781Model Lead Set/Patient Cable/Lead Upgrade KitRef 989803151761
Identity
- Trade Name
- TC ADDITIONAL LONG LEADS KIT: IEC EUDAMEDTC ADDITIONAL LEADS KIT: IEC EUDAMED
- Device Name
- Lead Set/Patient Cable/Lead Upgrade Kit EUDAMED
- Model / Reference
- Lead Set/Patient Cable/Lead Upgrade Kit EUDAMED989803151781 EUDAMED989803151761 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838117303 EUDAMED00884838117280 EUDAMED
- Basic UDI-DI
- 0884838BM1861N5 EUDAMED
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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: Electrocardiographic lead set, reusable
Tc Additional Long Leads Kit: Iec by Philips Medizin Systeme Böblingen GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
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 | 0884838BM1861N5 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED b0c1f502-21bc-4f40-8840-76026533efd2 61 fields · synced Jul 26, 2026
- EUDAMED 336fc9f8-33d7-4778-ab64-a897096e82d0 61 fields · synced May 19, 2026