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Concord Medical
EUDAMEDClass I (EU MDR)
Ref Concord Catalog Model 663021, 663022, 663023, 663024, 663025, 663121, 663122, 663123, 663124, 663221, 663222, 663223, 663224, 668 022, T145349, T145351, LSKM10116, LSKM10216
Identity
- Trade Name
- Concord Medical EUDAMED
- Device Name
- Sterile Disposable Skin Marker EUDAMED
- Model / Reference
- 663021, 663022, 663023, 663024, 663025, 663121, 663122, 663123, 663124, 663221, 663222, 663223, 663224, 668 022, T145349, T145351, LSKM10116, LSKM10216 EUDAMEDConcord Catalog EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897115790027 EUDAMED
- Basic UDI-DI
- 489711579630224G EUDAMED
- Direct Marketing DI
- 04897115790027 EUDAMED
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Concord Medical by Dongguan Concord Medical Products Ltd — Class I — 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 | 489711579630224G | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Concord Medical Products Ltd
- EUDAMED SRN
- CN-MF-000017708
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 5e2cf0e5-fb45-4f05-9a20-5682b5f13736 61 fields · synced Aug 2, 2026