Identity
- Trade Name
- Digit R EUDAMEDFDA UDI
- Generic Name
- Medical ruler, reusable FDA UDI
- Device Name
- Digit R EUDAMED
- Model / Reference
- DGR EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019140818 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191DGRV2 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- V0380 DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES EUDAMED
- GMDN Term
- Medical ruler, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Digit R by B&L Biotech — 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 | 88000191DGRV2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- B&L Biotech
- EUDAMED SRN
- KR-MF-000023296
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 02833f61-a12f-443a-a18f-7a3cc421a1c6 61 fields · synced Jul 12, 2026
- FDA UDI a68935ae-5d7a-4b3e-a279-02121d1bc59e 32 fields · synced May 30, 2026