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Dilator
EUDAMEDClass IIa (EU MDR)
Ref 004001Model 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F, 11F, 12F, 14F, 16F, 18F, 20F, 22F, 24F
Identity
- Device Name
- Dilator EUDAMED
- Model / Reference
- 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F, 11F, 12F, 14F, 16F, 18F, 20F, 22F, 24F EUDAMED004001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936841201259 EUDAMED
- Basic UDI-DI
- 69368412DL00RD EUDAMED
- EMDN Code
- C9002 VASCULAR AND FASCIAL DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Fascial tissue dilator, single-use
Dilator by Tianck Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Fascial tissue dilator, single-use.
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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 | 69368412DL00RD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tianck Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000007451
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c869c9eb-8041-4a9e-a5c3-47a04c7fbf91 61 fields · synced Jul 9, 2026