Identity
- Trade Name
- Maxmorespine EUDAMED
- Device Name
- Disposable Bipolar Probe 18 Gauge, 13.7cm EUDAMED
- Model / Reference
- 1001-BE 013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841019123843 EUDAMED
- Basic UDI-DI
- B-00841019123843 EUDAMED
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Maxmorespine by Kirwan Surgical Products Llc — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-00841019123843 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Kirwan Surgical Products LLC
- EUDAMED SRN
- US-MF-000008222
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED 783179d6-20c7-4a9f-a11f-495191a3faa9 61 fields · synced Aug 3, 2026