Identity
- Trade Name
- Tongue Depressor FDA UDI
- Generic Name
- Tongue depressor, examination, single-use FDA UDI
- Device Name
- Tongue Depressors EUDAMEDTongue Depressors, Wood, Sterile FDA UDI
- Model / Reference
- NA EUDAMED1609 FDA UDI
- Description
- Tongue Depressors, Wood, Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973069980023 EUDAMEDFDA UDI
- Basic UDI-DI
- 697306998TD-sterileHV EUDAMED
- FDA Product Code
- FMA FDA UDI
- EMDN Code
- V9001 TONGUE DEPRESSORS, SINGLE-USE EUDAMED
- GMDN Term
- Tongue depressor, examination, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6230 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Tongue Depressors by Dalian Rongbang Medical Healthy Devices Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697306998TD-sterileHV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dalian Rongbang Medical Healthy Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000022752
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED a0b8153a-6ca5-469e-b38c-3ce6b8177bc6 61 fields · synced Jun 18, 2026
- FDA UDI 37bff3f2-0c21-45b8-9f03-1ca6ef39337b 33 fields · synced May 30, 2026