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Superfirt
EUDAMEDClass I (EU MDR)
Ref 120X15X1.6MM(child)Model 150X18X1.6MM(adult),120X15X1.6MM(child)
Identity
- Trade Name
- Superfirt EUDAMED
- Device Name
- Tongue Depressor EUDAMED
- Model / Reference
- 150X18X1.6MM(adult),120X15X1.6MM(child) EUDAMED120X15X1.6MM(child) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976400130552 EUDAMED
- Basic UDI-DI
- 697640013TOD01H6 EUDAMED
- EMDN Code
- V9001 TONGUE DEPRESSORS, SINGLE-USE 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
Superfirt by Nanjing Superfit I & E Co., 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 | 697640013TOD01H6 | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Superfit I & E Co., Ltd.
- EUDAMED SRN
- CN-MF-000040037
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED be80e290-887f-419c-b470-fc582a33526b 61 fields · synced Jun 18, 2026