Identity
- Trade Name
- LawMax EUDAMEDLawMax Dilator FDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Device Name
- LawMax™ Dilator EUDAMED
- Model / Reference
- LT-DIL-16F EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938370131526 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06938370131526 EUDAMED
- 510(k) Number
- K123842 FDA UDI
- FDA Product Code
- DRE FDA UDI
- EMDN Code
- C058099 CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Vascular dilator, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1310 FDA UDI
- Market of Registration
- Bulgaria 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
LawMax by Lifetech Scientific (Shenzhen) Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06938370131526 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Lifetech Scientific (Shenzhen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001561
- Authorised Representative
- LifeTech Scientific (Europe) B.V. NL-AR-000000804
Sources (2)
- EUDAMED 3b083250-8a05-4c68-ade8-cfbc6e6414f7 61 fields · synced Jul 18, 2026
- FDA UDI 0f31f65a-cbe8-429d-ad95-25085977e139 33 fields · synced May 30, 2026