Identity
- Trade Name
- Depressors FDA UDI
- Generic Name
- Tongue depressor, surgical FDA UDI
- Device Name
- Tongue Depressors EUDAMED
- Model / Reference
- NA EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 16973069980013 EUDAMEDFDA UDI
- Basic UDI-DI
- 697306998TD-sterileHV EUDAMED
- Unit of Use DI
- 26973069980010 EUDAMED
- FDA Product Code
- FMA FDA UDI
- EMDN Code
- V9001 TONGUE DEPRESSORS, SINGLE-USE EUDAMED
- GMDN Term
- Tongue depressor, surgical 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 437f4e90-f43f-4ab2-9d74-10b128edcf00 61 fields · synced Jun 19, 2026
- FDA UDI 830f84b6-8d44-479b-8952-b026ba9497e2 32 fields · synced May 30, 2026